Total 12 Manager Associate Editor job vacancies in Quality Assurance / Control category in The United States of America

Your new company
My client, a global pharmaceutical and biotech company with a goal of contributing to healthcare innovation and environmental sustainability. They are focused on improving people's quality of life by preventing, alleviating, and curing diseases. They have a wide pharmaceutical portfolio, specialised in some of the following areas: Oncology, neuroscience, and rare diseases. There is an opportunity for a Quality Document Manager to join their Safety Surveillance and Aggregate Reports team on a 12-month rolling contract.
Inside IR35Onsite 2/3 days per week

Your new role
As a highly motivated individual, you will join their Safety Surveillance and Aggregate Reports team as an Associate Quality Document Manager, where you will perform QC review to ensure documents authored by the Safety Surveillance and Aggregate Reports (SSA) team or their vendors are of high quality. Also, support process improvement and other SSA functions, for example, vendor management, SharePoint management.

What you'll need to succeed
You will hold a bachelor's degree in biologic or natural science, or health care discipline. Advanced degree (PhD, MPH, NP, PharmD, etc.) is preferred.

You will possess good writing and editing experience within the pharmaceutical or biotech industry.

You will be familiar with pharmacovigilance and drug development, including knowledge of applicable clinical trial safety regulations and post-marketing safety regulations. Includes familiarity with case processing, expedited reporting rules, and safety database concepts.

You will have the ability to understand, interpret, analyse, and clearly present scientific and medical data in verbal and written format.

You will have the ability to interact collaboratively and effectively in a team environment.

You will possess strong organisational skills, including the ability to prioritise independently.

You will be proficient and comfortable using Microsoft Office (in particular, Word, Excel, and PowerPoint), SharePoint platforms and be familiar with Documentum-based systems and common safety database systems.


What you need to do now
Before you apply for this position, it is vital that you are in possession of a UK passport or relevant visa to work without restrictions in the UK and residing in the UK.

If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call Roberta Atkins on 03330106292

If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion about your career.

The primary purposes of this role includes:

• Drive PGCS Quality programs and policies compliance across site, by partnership with functional stakeholders.
• Key contributor/promoter to the advancement of Quality function across the sites; creating and driving critical/key business objectives in line with supporting/partnering with Operations, Supply Chain functions etc.
• Lead incident management and resolution and champion customer quality across Singapore. Site lead for Quality and Food safety crisis mgmt.
• Lead the implementation of the Singapore Quality Strategy including communication, project management and roll out activities.
• Lead continuous improvement culture/productivity initiatives to support site BPI process, demonstrating best practices to implement all quality improvements
• Drive, support and champion KPIs, key Quality metrics, etc.
• Act as a business partner to other functions whilst championing Quality, to ensure an extended and consistent quality focus.
• Be a key member of the Site Leadership team and value add in driving functional and site agenda.
• Support and provide strategic guidance around NPIs, validation, Total Quality System, Compliance, Capital investment, etc.
• Partnership with other functions ensuring change control risk assessment and validation in place for Network capacity projects and other key projects and significant changes.
• Financial Management; Budgetary and AOP responsibilities/input.
• Compliance; drive partnership with other functions through the Quality team to achieve key business goals for the control environment. Compliance with all regulations and 3rd party auditing requirements.
• Provide strategic quality leadership to the extended Quality Team
• Organisation design & sustainability of a highly effective team with appropriate succession plan. Encourage, manage & promote people-related activities/processes, partnering with HR
• Develop capability, personal growth and career development for direct reports, support these activities with DRs’ associated teams.
• Play in instrumental role in developing the overall team capability, supporting and aligning with overall plant culture.
• Ensure the smooth transition of new products to the Singapore facilities.
• Manage the complexity of additional materials, packaging and concentrate components from a quality perspective as portfolio expands
• Support and implement PGCS SC global quality initiatives
• Systems improvements (including IT systems) in terms of Processing, GMP, Product Safety, Disposition and Traceability.
• A requirement of the role is that you must adhere to all PepsiCo Health & Safety requirements.
• Any other ad hoc duties and projects as assigned

PRE-REQUISITES

• Bachelor’s Degree in Science, Food Technology, Chemistry or any other related discipline
• Minimum 7 years of relevant experience as a supervisor in operating Laboratory environment, manufacturing concern/MNC
• Ability to manage sennior stakeholders and leadershup team members
• Experience in People Management and prior supervisory skill
• Possess knowledge of and experience in GLP, HPLC / GC operation, SAP QM module and LIMS management
• Strong leadership presence, ability to manage and co-ordinate with cross-functional teams on investigation analysis, troubleshooting and issues resolution
• Knowledge of food safety quality standards such as HACCP and FSSC 22000
• Ability to lead change and drive behaviours
• Ability to organize and manage multiple priorities in high-pressure work environment
• Strong collaboration and influencing skills
• Excellent communication and interpersonal skills, both verbal and written with ability to clearly articulate ideas and proposals to all levels of the organization
• Positive and Can-do Attitude
• Willing to stretch and take additional responsibilities when needed
• Lead by example to others

We regret that only shortlisted candidate will be notified.

At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers. We foster an inclusive culture and are looking for diverse, talented people to join Alcon.

The Associate Manager/Sr. Specialist - Distributor Compliance is responsible for supporting the implementation and oversight of Distributor Life-cycle management mechanism in Alcon China. In this role, a typical day will include:

• Due Diligence: - Responsible for the assessment of due diligence reports, identifying and addressing red flags, making recommendations on the use of distributors.

• Training & Communication: - Provide compliance trainings and communications to distributors including onboarding, refresher and issue-based training. - Track and record delivery of training and communications.

• Distributor Compliance Program: - Support distributors in conducting self-assessment on their compliance program as well as provide compliance toolkit to assist on any gap-filling or risk mitigation. - Follow up and monitor the progress in the implementation of distributor compliance program.

• Monitoring & Assessment: - Conduct distributor site visits and on-site assessments. - Develop appropriate and consistent mitigation plans and ensure the completion of aligned mitigation items within expected timeline. - Support the timely completion of corrective and preventive actions for distributor internal audit findings.

• Investigation: - Assist in investigations to the extent requested.

WHAT YOU’LL BRING TO ALCON:

 Education • Bachelor degree or equivalent required

 Experience / Professional Requirements

• 3-4 years of experience working in a compliance programme within a business. This experience should preferably include progressive responsibility. • Audit experience preferred

• Experience in healthcare industry – medical device, pharma or Biotech is preferred

• Experience with channel compliance management preferred

• Demonstrates high level of professionalism

 Language and communication

• Verbal and written communication skills in English. Capable of fluent communication with English native speakers.

• Good cross functional communication and influencing skills, good project management experience.

Alcon Careers See your impact at alconcom/careers

How You Can Thrive at Alcon:

• Opportunity to work with a leading global medical device company.
• Collaborate with a diverse and talented team in a supportive work environment.
• Competitive compensation package and comprehensive benefits.
• Continuous learning and development opportunities.

Alcon Careers

See your impact at alcon.com/careers

  

ATTENTION: Current Alcon Employee/Contingent Worker

If you are currently an active employee/contingent worker at Alcon, please click the appropriate link below to apply on the Internal Career site.

Find Jobs for Employees

Find Jobs for Contingent Worker

At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers. We foster an inclusive culture and are looking for diverse, talented people to join Alcon. ​

The (Associate) Manager/Sr. Specialist - Distributor Compliance is responsible for supporting the implementation of Distributor Life-cycle management mechanism with a primary focus on distributor training in Alcon China.

In this role, a typical day will include:

Major Accountabilities:

• Training & Communication:
  - Identify and analyse training needs, support line manager to develop and implement compliance related training strategies to ensure optimal delivery focusing on effectiveness, clarity, and understandability.
  - Prepare appropriate training and communication materials in accordance with the training strategy and plan or to fulfill ad-hoc internal clients’ need.
  - Provide compliance trainings and communications to distributors and employees including onboarding, refresher and issue-based training.
  - Facilitate the administrative supports of large-scaled compliance training (e.g., annual distributor meeting, sales meetings)
  - Continuously collect feedback on the training program to identify improvement spaces.
  - Track and record delivery of training and communications.
• Distributor Compliance Program:
  - Support distributors in conducting self-assessment on their compliance program as well as provide compliance toolkit to assist on any gap-filling or risk mitigation.
  - Deliver policy clarification and interpretations to help distributors mitigate compliance risks and achieve legitimate business objectives.
• Monitoring & Assessment:
  - Conduct distributor site visits and on-site assessments.
  - Develop appropriate and consistent mitigation plans and ensure the completion of aligned mitigation items within expected timeline.
  - Support the timely completion of corrective and preventive actions for distributor internal audit findings.
• Investigation:
  - Assist in investigations to the extent requested.

WHAT YOU’LL BRING TO ALCON:

Education

• Bachelor degree or equivalent required

Experience / Professional Requirements

• 3-4 years of experience working in a compliance programme within a business. This experience should preferably include progressive responsibility.
• Audit experience preferred
• Experience in healthcare industry – medical device, pharma or Biotech is preferred
• Experience with channel compliance management preferred
• Demonstrates high level of professionalism

Language and communication

• Verbal and written communication skills in English. Capable of fluent communication with English native speakers.
• Good cross functional communication and influencing skills, good project management experience.

How You Can Thrive at Alcon:

• Opportunity to work with a leading global medical device company.
• Collaborate with a diverse and talented team in a supportive work environment.
• Competitive compensation package and comprehensive benefits.
• Continuous learning and development opportunities.

Alcon Careers

See your impact at alcon.com/careers

  

ATTENTION: Current Alcon Employee/Contingent Worker

If you are currently an active employee/contingent worker at Alcon, please click the appropriate link below to apply on the Internal Career site.

Find Jobs for Employees

Find Jobs for Contingent Worker

We are looking for motivated and analytical individuals who play an important role in enhancing Changi Airport's operational performance in safety, capacity and efficiency. Your role requires you to have in-depth knowledge of airfield and flow to manage airside operations at Changi Airport.

To ensure a high-performing airside operation, you will be the key conduit between stakeholders which includes airlines, ground-handlers, Air Traffic Control, CAG divisions, etc. You will provide operational guidance and support to strive for optimal on-ground execution to enhance Changi’s safety, capacity and efficiency. You will perform quality assurance and engage stakeholders to improve operational processes. You will monitor and analyse the factors that result in sub-optimal performance for the airside operations, provide recommendations and work with stakeholders to formulate solutions to resolve them. You will also be involved in projects related to optimize Changi Airport’s capacity and improving efficiency of business operations. You will develop proposals/ recommendations to solve complex operational challenges and develop contingency plans to handle operational incidents.

Requirements:

• Good degree in any discipline with at least 2 years of work experience . Familiarity with airport planning/operations, ground handling operations is a plus.

• Strong written and verbal communication skills, to be able to put your ideas across to internal and external stakeholders.

• Data analytical capabilities and programming know-how will be advantageous.

• Motivated team player, able to handle fast-paced projects and adapt to constant changes.

• Fast learner with the willingness to contribute to a wide spectrum of operational areas.

Job Description

- Handle all Singapore direct and indirect tax matters to ensure that statutory reporting requirements are met, including independently collating and liaising with internal and external stakeholders for information and submission matters.

- Handle monthly, quarterly and year- end closing, including but not limited to indirect tax computation, tax provision computation and deferred tax calculation.

- Review payment list and liaising with internal stakeholders to file the Singapore withholding tax.

- Manage tax queries from the tax authorities.

- Keep up to-date on new or changes in tax regulations, assess the impacts to the current workstream, and to update other stakeholders if required.

- Coordinate with team members in other countries on projects and initiatives

- Support the business units in their initiatives, including participating in discussions and providing tax analysis

- Assist or lead on any ad-hoc duties and projects as assigned

‎

Requirements

- Bachelor degree from accountancy and / or equivalent professional certification, with at least 5 years of working experience

- Strong communication skills so as to be able to independently engage with regional stakeholders and external consultants

- Highly motivated team player that works collaboratively with other stakeholders

‎

If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!

Quality Assurance and Safety Management

• Collaborate with related functions and be responsible for maintaining and configuring QMS and ISO13485 in accordance with change control processes.
• Lead the company's compliance activities according to PMD Act/ISO13485/15189 and applicable requirements.
• Maintain both QMS and GVP under MAH, including Shonan laboratory.
• Conduct internal audits and top management reviews based on the regulations.
• Communication with the regulatory authorities and notified bodies regarding safety information.
• Collect and manage safety information and lead necessary action.
• Report and respond to related regulatory authorities.
• Ensure that all SOPs are written following applicable regulatory and company requirements.

Regulatory Affairs

1. Responsible for activities that lead and maintain regulatory promotion code for In Vitro Diagnostic (IVD) devices, medical devices, and RUO products.
2. Support to create and review a submission package and product insert.
3. Lead QMS assessment regarding submission of new products to PMDA
4. Maintain and manage FMR with collaborating GHI.
5. Lead the company's compliance activities according to the PMD Act/Promotion guideline/ Fair Competition Code and applicable requirements.
6. Maintain and change control MAH and IVD sales license.

About the company

Our client is a global pharmaceutical company dedicated to advancing healthcare through innovative medicines and solutions, and they are looking for a highly motivated Quality Assurance Associate/Manager to join the team.

About the job

As a Quality Assurance Associate/Manager for the organization, you will

• Attain and maintain necessary certifications such as GMP, GDP and maintain the master list of products.
• Guarantee compliance with regulatory requirements and local standards in all aspects
• Oversee the initiation, investigation, reporting, trending, and communication of external inspections, complaints, recalls, deviations, CAPA, counterfeiting, tampering incidents, supplier performance, and other pertinent quality measures to the appropriate stakeholders and management.
• Ensure compliance with GDP and regulations in repacking, storage, distribution, and transport.
• Manage changes through a change control system.
• Partake in training programs and activities
• Establish and maintain internal audit procedures, ensuring compliance.

Skills and experience required

• To succeed in this role, you must possess a Degree in related disciplines
• Preferably with minimum 3 years of relevant experience in the GMP/GDP environment
• Registered Pharmacist License required
• Strong ability to communicate and influence key decision makers

Description

1. Contribute to the establishment, continuous improvement and maintenance of the Quality Management System (QMS) in ROPU ASKAN by ensuring that all external (e.g. GMP, GDP, GDPMD, GSP, GIP) and internal BI requirements (e.g. Policies, OCS, OCP, ACP) are implemented at ROPU and each OPU, monitored for performance/adherence and improved, if required.

2. Support OPU Commercial Quality (CQ) Managers/Leads, Specialists, Associates and LPCOs) in executing key defined steps in relevant quality processes where such activities are centralized at ROPU.

3. Support the Commercial Quality Strategy for the ROPU together with the Head of Commercial Quality ROPU ASKAN and respective Corporate and ROPU Management.

4. Support the Head of Commercial Quality ROPU ASKAN and Commercial Quality Manager ROPU ASKAN and DMS/LMS Specialist ROPU ASKAN in ensuring appropriate Quality oversight related to GMP and GDP/GDPMD/GSP/GIP in the ROPU including:

• Management of external service providers in all quality relevant aspects during the life cycle of a contract beginning with issuance until termination to ensure local supply and manufacture of products or services with acceptable quality, in full regulatory compliance and in accordance with contractual obligations and BI guidelines.

• Performing GMP/GDP/GDPMD/GSP/GIP audits at suppliers and external partners (qualification and regular audit), including follow-up of CAPAs at 3rd parties.

• Implementing/revising relevant GMP/GDP/GDPMD/GSP/GIP quality systems related to commercial product supply in the ROPU to meet the continual needs of the company and the local authorities and ensure that products and processes/systems are delivered to the customers with a consistent high quality standard and in accordance with BI requirements and the local legislations.

• Knowledge management within ROPU by supporting best practice sharing and ensuring training across the ROPU.

• Efficient implementation of standards within the ROPU by maintaining a common document management system; implementation of OCS, OCPs and further Corporate documents; monitor rollout and by standardization of processes.

• Continual quality and compliance improvement within ROPU by identifying optimization potentials and by monitoring OPU performance via self -inspection/self-assessment program.

• Assume role as ROPU system owner (Local MSO), SME, administrator and key user for relevant Quality Systems (E.g.Investigation, CAPA, change control, and product complaints etc).

5. Support the maintenance of trainings within the electronic training system and management of controlled documents in the electronic document management system for all Business unites, functions, departments and countries within ROPU ASKAN.

6. Support to ensure proper implementation of global procedures related to training and document management for ASKAN and continuous improvement of training and document management system in ROPU ASKAN.

7. Provide support to management/execution of OPU Commercial Quality operation/activties (as needed).

8. Serve as backup-up support for OPU Commercial Quality responsible persons on OPU commercial quality operation/activities (as needed).

9. Provide commercial quality input/support to certain business initiatives, projects, requests as per requirements and established timelines as needed.

10. Take on and/or support any other tasks assigned.

Duties & Responsibilities

• As Local MSO, SME, administrator and key user for Quality System Management and/or supporting:

- Creation and maintenance of relevant quality system for regional/local SOPs/Working Instructions (e.g. write, review, approve, periodic review etc);

- Ensuring that applicable Corporate Procedures are transferred into ROPU or local SOPs/Working Instructions

- Ensuring that training on relevant Quality SOPs/Working Instructions are properly performed and documented before implementation.

- Ensure system records are tracked, updated and closed as per established requirements/timelines.

- Ensure system KPIs are tracked, reported and met as per established requirements/timelines.

- Analyze any significant changes in the GMP/GDP/GDPMD/GSP/GIP environment and identify need for SOP/Working Instructions writing and/or communication to Corporate Quality (Operations Regulatory Intelligence “ORI”).

• Provide to other local MSO, SME, Administrator, and key users for Quality System Management on above activities if needed.

• Provide support to management/execution of OPU Commercial Quality operations/activities (as needed).

• Serve as backup-up support for OPU Commercial Quality responsible persons on OPU commercial quality operation/activities (as needed).

• Present process evaluations and implement agreed changes for continuous improvements to the ROPU Quality Systems and Quality Manual.

• Represent ROPU ASKAN Commercial Quality and act as an interface to Global Corporate/Global Quality Organization; give feedback to Corporate/Global level quality initiatives and take actions to ROPU/OPU levels.

• Represent ROPU ASKAN Commercial Quality team or Head of Commercial Quality ROPU ASKAN to provide input/support for certain business initiatives, projects, requests, matters as per relevant requirements and established timelines as needed.

• Provides consistent global, regional and local business support for LMS through:

- Coordinating global, regional and local assignment process.

- Providing technical expertise (system troubleshooting, advice and assistance to Learners, Curriculum Owners, Line Managers, etc.).

- Promoting best practices in the utilization of LMS.

- Supporting the globally defined training process within ROPU ASKAN.

- Supports the maintenance and development of the regional training process, including active support for the MTGC (Mandatory Training Governance Council), and creation and execution of related procedures, guidelines and decisions.

- Support global, regional and local curriculum owners in the creation and maintenance of curricula, and the assignment of curricula to intended learners in a timely and structured manner.

- Ensure training assignment of regional and local training in a coordinated manner, and within the given timelines according to the globally defined processes.

- Ensure a comprehensive tracking of all learning, both e-learning as well as group and face to face learning.

- Provide support during audits and inspections in case of questions regarding training and document management.

- Carefully track and report training and document management KPIs, and set activities for improvement of KPIs as needed.

- Support knowledge exchange and best practice sharing regarding LMS, within ASKAN as well as global BI network.

- Be the Deputy Process owner for the processes of Training and Document Management in ROPU ASKAN.

- Be the back-up to assume the role & responsibilities of DMS & LMS Specialist, ROPU ASKAN role when needed.

• Provide support as needed to ensure lean and appropriate SOP development within ROPU ASKAN.

• Establishing a system to support authors of controlled documents, in creation, maintenance/update as well as learning assignment to target audience.

LMS continual improvement:

• Provide support for the further development and maintenance of the training and document management systems and processes within the globally provided framework.

• Initiate efforts for effective and efficient system use.

• Act as technical and business expert in the use of LMS and maintain system quality, report on standard system metrics, support MTCG periodic curriculum review.

Requirements

· Bachelor of Science degree in Chemistry, Pharmacy, Chemical Engineering, or related science diploma with relevant work experience.

· 5-7 years Quality experience in pharmaceutical or biologics or medical devices MNC. Any GMP quality experience is a plus.

· Minimum 5 years experience in country/regional commercial quality operation/activities management and execution in pharmaceutical or biologics or medical devices MNC. Any regional commercial quality experience is a plus.

· Sound and direct experience/knowledge (2-4 years) in training management and controlled document management system and using electronic system for training and controlled document management.

· Thorough knowledge of GDP quality/regulatory requirements with practical expertise in commercial quality operation/activities in pharmaceutical/vaccines/medical devices industry.

· Works well in both a team-orientated environment and independently

· Attention to detail, good organizational skills, flexibility

· Sense for urgency and efficiency

· Demonstrates ability to manage multiple activities

· Excellent oral and written communication skills in English language

· Communicates effectively results and project status both internally and externally

· Prepares technical reports including executive summaries and management presentations

· Demonstrates strong analytical skills, is able to judge when more information is needed, where to obtain it and to draw sound conclusions from available information

· Demonstrates mature judgment and strong decision-making skills regarding project and product issues

· Is able to deal with complexity (critical thinker)

About The Company

KGI Securities is a leading multi asset brokerage firm with presence across several countries in Asia and a pioneer member of the Securities & Derivatives, Trading and Clearing Member of Singapore Exchange, ICE Futures Singapore and ICE Clear Singapore.

We hold a Capital Markets Services License, is regulated by the Monetary Authority of Singapore (MAS) and is also an equal opportunity employer.

About The Job

The duties of Compliance officer (Manager) include providing guidance and training of regulations, consultation of securities and futures trading laws, as well as timely update of applicable laws and regulations. The Compliance officer (Manager) will also be responsible for supervising the periodic self-assessment of regulatory compliance among all departments in the organisation.

Job Responsibilities

• Develop trade surveillance policies and procedures for monitoring trading activities for any trading misconduct and money laundering suspicious transactions.
• Carry out daily review of trade surveillance exception reports, follow-up on exceptions noted and determine and recommend remedial or preventive actions.
• Review trade error reports and follow up on any irregularities noted.
• Escalate any breaches of regulatory requirements or misconduct or company policies.
• Conduct periodic review of company trade surveillance policies and procedures with the view to implement enhancements, if any to existing practices
• Conduct investigation into any complaints or feedback received on any potential trading irregularities and any breaches of regulatory requirements noted during reviews or reports received on breaches.
• Develop compliance review programmes, Compliance workplans, self-assessment questionnaire and any other compliance programmes as may be required by Head of Department, front and back office, parent company, regulators, and authorities.
• Liaise with relevant regulators, Head Office on any major findings and other compliance reporting requirements.
• Provide compliance advisory support and guidance to back and front office regarding compliance with applicable laws, regulations, and rules.
• Attend and participate in local management, regional and Board meetings,
• Review and process registration of trading representatives
• Carry out awareness briefing and staff training on regulatory requirements, company policies and procedures.
• Assist Compliance Team to work on compliance tasks as may be required by Head of Department
• Assist Head of Department / Compliance Team to carry out any compliance tasks or projects as and when necessary, as directed by the Head of Department.
• Assist Head of Department and/or Compliance team in carrying out the advisory functions of the Department.
• Any other ad-hoc responsibilities assigned.

Requirements:

• Degree holder with 3-5 years of relevant experience
• Familiarity with the relevant laws, regulations and exchange rules in the securities and futures market is an added advantage.
• Meticulous, positive attitude and pro-active
• Strong communication, interpersonal, analytical, and organizational skills
• Team player yet able to work independently and interact effectively with stakeholders at all levels.
• Candidates with relevant experience in exchanges (e.g. in market surveillance or supervision departments), public accounting firms, securities and futures brokerage firms and other financial institutions are encouraged to apply

We offer attractive salary package and long-term career development to the successful candidates. You are invited to email your cover letter and full resume to hr_recruit.sg@kgi.com.

We regret that only short-listed candidates will be notified.

Responsibility and Accountabilities:

Be accountable for an effective Quality Management System established / implemented, maintained and operated in line with current GxP (e.g. GDP, GMP) requirements of PIC/S, local regulatory standards, and Mundipharma standards for all product classes. Awareness of trends in industry and implementing necessary changes.

Delegation of responsibility may be given to competent personnel; however, the accountability remains with the responsible person. Any delegated activities should be documented (keeping appropriate records) and approved - preferably in a RACI Matrix.

Including but not limited to as listed in below sections. And other tasks as assigned by supervisor in line with business and regulatory requirements.

1. Licensing

• Ensuring appropriate certification (e.g. GMP, GDP, GDPMDS, GDPMD, GQP, ISO, HACCP) is attained and sustained as required.
• Provide expert advice on licensing requirements for IAC.
• Ensure that correct licenses are held at all times, if necessary.
• Maintain and control the master list of products for IAC.
• Liaise with regulatory to ensure that the information in the product list is kept current and that all product information and labelling are in compliance with local and where applicable international regulations, codes and standards.
• Identify problems and implement effective solutions.
• Liaise with regulatory authorities in collaboration with the regulatory department for quality related matters.

2. Quality Managment

• Information to senior management if any aspect of the business or plant’s operations is not in accordance with GxP guidelines.
• Ensuring all aspects of product handling and distribution are performed in accordance with regulatory requirements, local quality standards and Mundipharma regulations.
• Implementation of quality and GxP regulations as well as any other relevant standards, maintaining awareness of trends in industry and implementing necessary changes.
• Ensuring external inspections, complaints, recall, deviations, CAPA, incidents of counterfeiting and tampering, supplier performance and other relevant quality performance measures are raised, investigated, reported, trended and communicated to those required and management.
• Ensuring suitability, approval and auditing of suppliers and customers etc. where applicable.
• Approving any subcontracted activities which may impact on GxP (e.g. GDP) or on corresponding equivalent (e.g. ISO etc.).
• Ensuring quality risk management principles. (E.g. Establishing emergency and safety plans, if applicable)

3. Personnel

• Ensures the initial and continuous training programme is implemented and maintained. Plans and records should reflect training activities.

4. Documentation

• Ensuring the management of authorized activities and the accuracy and quality of records. Records should be available as evidence and traceability of activities performed with respect to the quality, strength, purity, safety, identity and traceability of the product and integrity of the pack.
• Ensures that documentation and records are managed throughout their life cycle.
• Ensures an effective CAPA system for recording of all actions for correction, prevention and improvement, with monitoring for closure in a timely manner.

5. Operations

• Ensure the compliance of repacking, relabeling, storage, distribution and transport are in accordance with GDP or applicable regulations, licensing and Mundipharma standards and responsibilities defined by technical agreement and approved prior to use.
• Ensures changes related to product, third parties, key business activities, artwork, etc are raised, evaluated and implemented via a change control system. o Assisting in audit, approval, supervision and co-ordination of third party activities.
• In cases where a distribution IAC is also a Marketing Authorisation holder for a product, to ensure the performance of Annual Review or Trend analysis of products; evaluating the results and taking appropriate action and in a timely manner to facilitate reporting of the restriction in supply (for example due to manufacturing constraints) to the relevant competent authorities, in accordance with its legal obligations.
• Ensuring that batches of products should not be transferred to salable stock before assurance has been obtained in accordance with written procedures, that they are compliant and authorized for sales. (i.e. decision for market release of product).
• Ensuring that any additional requirements imposed on certain products by national legislation are adhered to. (E.g. Surveillance of the quality of Mundipharma products and the compliance with legal requirements).
• Ensure that Mundipharma security procedures are implemented for controlled drugs.
• Ensure that due diligence and quality evaluation is performed as per Mundipharma procedures and policies.
• Ensures that controlled drugs are managed as per authority requirements, including reconciliation and witness of destruction.

6. Complaints, Returns, Suspected Falsified Products and Product Recalls

• Establish and maintain receipt, investigation, tracking, trending and communication of complaints. This includes notification to authority as per the current regulatory requirements. Ensure escalation and notification in line with regulatory and Mundipharma standards and timelines.
• Deciding on the final disposition of returned, rejected, recalled or falsified/counterfeit products.
• Approving of any returns to saleable stock.
• Ensure an effective process for the management of Rapid Alerts (e.g. Field Alerts, Field Safety Notice Field Safety Corrective actions, etc.).

7 Self-inspections

• Ensuring that internal audit programme is established, maintained and communicated. Actions identified should be tracked as CAPA. Schedule should reflect requirement for audit on at least an annual basis.

Qualifications and Experience:

• Degree in Pharmacy, Chemistry or related disciplines/ Registered Pharmacist.
• A minimum of 5 years' experience in GxP (e.g. Good Distribution Practice) for at least one of the preferred categories or equivalent.
• A minimum 3 years being responsible for the operational management of a GDP/ GMP Quality Management System including decision making for product release or equivalent.
• Trained internal auditor for GMP/GDP
• Proficient in the use of Microsoft Office Applications
• Fluent in Spoken and Written English

 

Additional Job Description:

Primary Location:

SG Singapore

Job Posting Date:

2023-09-20

Job Type:

Permanent

Responsibility and Accountabilities:

Be accountable for an effective Quality Management System established / implemented, maintained and operated in line with current GxP (e.g. GDP, GMP) requirements of PIC/S, local regulatory standards, and Mundipharma standards for all product classes. Awareness of trends in industry and implementing necessary changes.

Delegation of responsibility may be given to competent personnel; however, the accountability remains with the responsible person. Any delegated activities should be documented (keeping appropriate records) and approved - preferably in a RACI Matrix.

Including but not limited to as listed in below sections. And other tasks as assigned by supervisor in line with business and regulatory requirements.

1. Licensing
o Ensuring appropriate certification (e.g. GMP, GDP, GDPMDS, GDPMD, GQP, ISO, HACCP) is attained and sustained as required.
o Provide expert advice on licensing requirements for IAC.
o Ensure that correct licenses are held at all times, if necessary.
o Maintain and control the master list of products for IAC.
o Liaise with regulatory to ensure that the information in the product list is kept current and that all product information and labelling are in compliance with local and where applicable international regulations, codes and standards.
o Identify problems and implement effective solutions.
o Liaise with regulatory authorities in collaboration with the regulatory department for quality related matters.

2. Quality Management
o Information to senior management if any aspect of the business or plant’s operations is not in accordance with GxP guidelines.
o Ensuring all aspects of product handling and distribution are performed in accordance with regulatory requirements, local quality standards and Mundipharma regulations.
o Implementation of quality and GxP regulations as well as any other relevant standards, maintaining awareness of trends in industry and implementing necessary changes.
o Ensuring external inspections, complaints, recall, deviations, CAPA, incidents of counterfeiting and tampering, supplier performance and other relevant quality performance measures are raised, investigated, reported, trended and communicated to those required and management.
o Ensuring suitability, approval and auditing of suppliers and customers etc. where applicable.
o Approving any subcontracted activities which may impact on GxP (e.g. GDP) or on corresponding equivalent (e.g. ISO etc.).
o Ensuring quality risk management principles. (E.g. Establishing emergency and safety plans, if applicable)

3. Personnel
o Ensures the initial and continuous training programme is implemented and maintained. Plans and records should reflect training activities

4. Documentation
o Ensuring the management of authorized activities and the accuracy and quality of records. Records should be available as evidence and traceability of activities performed with respect to the quality, strength, purity, safety, identity and traceability of the product and integrity of the pack.
o Ensures that documentation and records are managed throughout their life cycle.
o Ensures an effective CAPA system for recording of all actions for correction, prevention and improvement, with monitoring for closure in a timely manner.

5. Operations
o Ensure the compliance of repacking, relabeling, storage, distribution and transport are in accordance with GDP or applicable regulations, licensing and Mundipharma standards and responsibilities defined by technical agreement and approved prior to use.
o Ensures changes related to product, third parties, key business activities, artwork, etc are raised, evaluated and implemented via a change control system.
o Assisting in audit, approval, supervision and co-ordination of third party activities.
o In cases where a distribution IAC is also a Marketing Authorisation holder for a product,
▪ ensure the performance of Annual Review or Trend analysis of products; evaluating the results and taking appropriate action.
▪ in a timely manner to facilitate reporting of the restriction in supply (for example due to manufacturing constraints) to the relevant competent authorities, in accordance with its legal obligations.
o Ensuring that batches of products should not be transferred to salable stock before assurance has been obtained in accordance with written procedures, that they are compliant and authorized for sales. (i.e. decision for market release of product).
o Ensuring that any additional requirements imposed on certain products by national legislation are adhered to. (E.g. Surveillance of the quality of Mundipharma products and the compliance with legal requirements).
o Ensure that Mundipharma security procedures are implemented for controlled drugs.
o Ensure that due diligence and quality evaluation is performed as per Mundipharma procedures and policies.
o Ensures that controlled drugs are managed as per authority requirements, including reconciliation and witness of destruction.

6. Complaints, Returns, Suspected Falsified Products and Product Recalls
o Establish and maintain receipt, investigation, tracking, trending and communication of complaints. This includes notification to authority as per the current regulatory requirements. Ensure escalation and notification in line with regulatory and Mundipharma standards and timelines.
o Deciding on the final disposition of returned, rejected, recalled or falsified/counterfeit products
o Approving of any returns to saleable stock
o Ensure an effective process for the management of Rapid Alerts (e.g. Field Alerts, Field Safety Notice Field Safety Corrective actions, etc.).

7 Self-inspections
o Ensuring that internal audit programme is established, maintained and communicated. Actions identified should be tracked as CAPA. Schedule should reflect requirement for audit on at least an annual basis.

Qualifications and Experience:

• Degree in Pharmacy, Chemistry or related discipline/ Registered Pharmacist
• A minimum of 5 years’ experience in GxP (e.g. Good Distribution Practice) for at least one of the preferred categories or equivalent.
• A minimum 3 years being responsible for the operational management of a GDP/GMP Quality Management System including decision making for product release or equivalent.
• Trained internal auditor for GMP/GDP
• Proficient in the use of Microsoft Office applications
• Fluent in Spoken and Written English