Total 12 Senior Executive Quality Assurance job vacancies in Quality Assurance / Control category in Malaysia

Job Summary:

Support in the daily business operations for drop shipment activities, including packing, quality check and preparation of delivery of pharmaceutical and nonpharmaceutical products for orders. Assist in drug stock management activities.

Core Responsibilities:

· Assist in the implementation of quality assurance and quality improvement projects and activities to meet the Good Distribution Practice and Good Distribution Practice Medical Device Singapore (GDP & GDPMDS) standard

· Assist in internal audits, record checking and implementation of post-audit corrective actions

· Support in preparing document, forms, chart and SOPs.

· Assist pharmacists in product recalls

· Assist in inventory management of pharmaceutical and nonpharmaceutical products

· Ensure proper storage and handling of drug stock

· Highlight equipment failures and unusual activities to pharmacists/supervisors

· Maintain the proper functioning of facilities

· Suggest improvements to workflows and procedures

· To carry out any additional job-related duties that may be assigned from time to time

Job Requirements:

· Diploma in Pharmaceutical Science or equivalent

· Experience in the pharmaceutical sector or Quality Management Systems specific to Good Distribution Practices (GDP or GDPMDS) preferred

· Organised, meticulous and pay attention to details.

• Reviews and updates organization Quality policy and objectives for Management’s approval
• Reviews & updates company Occupational Health & Safety policy & objectives for Management’s approval
• Prepares, reviews and updates Quality Management System (QMS) and Occupational Health and Safety Management System (OHSMS) manuals, procedures and forms
• Interprets and implements quality assurance standards and procedures
• Reviews the implementation and effectiveness of standards and procedures
• Plans & conducts internal audits for ISO 9001:2015 & ISO 45001:2018 as scheduled in the annual work plan
• Plans and conducts Management Review Meeting for ISO 9001:2015 and ISO 45001:2018
• Manages 3rd party certification body audits for ISO 9001:2015, ISO 45001:2018 and BizSafe STAR
• Co-ordinates with respective Departments for the preparation for external audits
• Follow-up on post audits activities
• Manages Document Control for all QMS and OHSMS documents to ensure latest revision
• Supports and works with various departments in procedure reviews and updates, ensures changes are incorporated in a timely manner and assists in assessment of these changes
• Identifies training needs and organizes training interventions to meet quality standards
• Conducts Factory Acceptance Test (FAT), workshop fabricated items inspection and onboard completion inspection both internally and externally
• Prepares inspection reports of inspection outcomes and updates overall inspection status summary
• Liaises with Clients and CLASS Surveyors on external inspection
• Monitors and expedites closure of all non-conformances of the company, if any
• Responsible to create and review Risk Management Plan for projects

About SCG

SCG Cell Therapy Pte Ltd is a clinical-stage biotechnology company focusing on the development of novel immunotherapies for patients with pathogenic infections and it associated cancers. Our strategy is to harness patient's immune system by redirecting cellular responses toward pathogens and its associated cancer using adoptive cell therapy, bispecific antibodies and vaccines.

Position Summary

The candidate will serve as the main document controller and training administrator under the QA team, under the supervision of the QA manager. He/she will also be expected to contribute to the maintenance and continuous improvement of the site’s record and document management system.

Core responsibilities

• Oversee the creation, revision, and distribution of documents in adherence to established site procedures and guidelines
• Manage the creation, revision, and distribution of documents in accordance with established procedures
• Provide training to employees on document control processes, standards, and systems
• Review documentation and records for ALCOA+ and compliance with regulatory requirements
• Conduct routine onsite inspections of record keeping and form completion during production and QC procedures
• Manage, coordinate and evaluate employee training programs
• Collaborate with subject matter experts to design and update training materials
• Support audits by regulatory authorities and notified bodies when required
• Identify areas within the document control and training programs for improvement

Role requirements

• Diploma/Degree, preferably in the chemical or life sciences
• At least 1 year of experience in a document controller role, or 3 years in a GMP environment
• Familiarity with the design, implementation, and evaluation of training programs
• Experience with regulatory audits is a plus

Key Responsibilities

• Lead and drive quality improvement initiatives within the treatment and patient care domain
• Collaborate with clinical and operational teams to identify pain points and develop strategic solutions
  for improvement
• Engage stakeholders, including medical professionals, administrators, and support staff, to understand
  their challenges and implement effective problem-solving strategies
• Implement and leverage innovative approaches to enhance treatment methodologies and patient care experiences
• Drive the Company's Journey app project end-to-end including requirements gathering, design, development, testing, launch and adoption.
• Develop and execute project plans and timelines
• Create, track and manage project budgets and resource plans
• Set project milestones and ensure adherence to timelines and budget
• Drive project progress and communicate critical updates and reports to relevant stakeholders in a timely manner
• Conduct functional testing to verify that the proposed solution aligns with user requirements and complete User Acceptance Testing (UAT) to ensure project completeness
• Identify potential risks and issues with the project and escalate to managers when required.
• Liaise with external vendors and partners involved in the project development.
• Develop a marketing and adoption plan to drive usage of the app among patients and caregivers.

Key Requirements

• Bachelor's degree in IT, Computer Science or related field
• Knowledge of mobile platforms, technologies and trends
• Excellent analytical and problem-solving skills
• Budgeting and resource planning experience
• Experienced in facilitating workshops and conducting trainings
• Excellent communication and interpersonal skills to collaborate effectively with diverse teams
• Self-starter with a strong sense of urgency and a positive “can do” attitude

To apply, please visit www.gmprecruit.com and search for Job Reference: 24351

To learn more about this opportunity, please contact Gia Grace at gia.grace@gmprecruit.com

We regret that only shortlisted candidates will be notified.

GMP Technologies (S) Pte Ltd | EA License: 11C3793 | EA Personnel: Bautista Gia Grace De Guzman | Registration No: R23111973

The Opportunity
We are looking for an experienced Senior Associate Quality Assurance (QA) to join the CSL Behring Quality team based at Broadmeadows (Australia) on a fixed term basis until 31 July 2025 (maternity leave replacement). Reporting to the Manager QA Value Stream Release, you will review batches of intermediate, semi-finished and finished product and authorise their release. You will also help review quality issues related to post-release actions including Product Technical Complaints (PTC) and Adverse Event Investigations (AE).

The Role
Based onsite at Broadmeadows and working with a diverse team, you will:

Review the relevant product portfolio batch / release documentation to ensure that intermediates and final product are suitable for further processing or release and report any issues identified;
Perform detailed review of batch records for starting materials, intermediate and final products;
Perform batch dispositions of plasma, intermediates, and semi-finished including completing SAP transactions and preparing documentation required;

... Click here to view more detail / apply for Senior Associate Pharmaceutical Quality Assurance

As a Senior Quality Assurance Executive, you will be responsible for maintaining and improving our organization's Quality Systems.

• Basic $3,500 - $4,000 (depends on experience)
• Monday to Friday 9am to 6pm
• Location - North, Yishun

Responsibilities:

• Administration of CAPA, DCR, Internal Audit, and CCR processes within the organization.
• Assisting the Quality Manager in managing Quality Systems across the organization.
• Monitoring and reviewing quality indicators and quality control reports across departments.
• Ensuring compliance with regulatory requirements such as the MOH Healthcare Services Act and other relevant regulations.
• Maintaining accreditation and certification standards such as AABB, FACT, GDP-MDS SS 620, and others as required for our services/products.
• Conducting root cause analysis, rectification, and process improvement for deviations/non-conformances (CAPA).
• Performing risk assessments for company activities.
• Conducting Internal Audits and supporting External Audits to ensure compliance with regulatory and accreditation standards.
• Assisting regional offices on quality matters.
• Managing the Document Control system and ensuring staff compliance with approved documents.
• Supporting supplier/vendor qualification and audits.
• Assisting in change control activities.

Requirements:

• Diploma or Degree in a relevant field with at least 3 years of working experience in Quality Systems, preferably in healthcare and/or Health Services.
• Experience in administration of CAPA (Corrective and Preventive Actions), DCR (Document Change Requests), Internal Audit, and CCR (Customer Complaint Records) within an organization.

Interested applicants, click APPLY NOW or text +65 9759 6862 for confidential discussion.

only shortlisted applicants will be notified

OH ZI YI, JOEY | R22107510

MTC CONSULTING PTE LTD | 15C7752

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Senior Quality Engineer
Job No: 671305
Brisbane - Inner Suburbs & CBD
Permanent Full Time
IT
Pay Band 5

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Senior Software Quality Engineer (Identity)

Work with a talented Quality Engineering team in Bank Technology
Were looking for an experienced Quality Engineer/Lead with strong automation knowledge
Brisbane location with great benefits and work flexibility

The Role
The Senior Software Quality Engineer (identity) works with the team to perform and guide on all types of testing, ensuring that the quality of the solution and resulting test artefacts meet the needs and requirements of our customers. You will be an advocate for testing, automation, and continuous improvement.




... Click here to view more detail / apply for Senior Quality Engineer

As part of the Quality Team ; the role will include strong and visible leadership to the Trust across the whole quality, risk and patient safety agenda; including the provision of expert governance knowledge in an acute hospital setting and will take part in the Trust Wide On Call rota. The post holder will lead on the Trust's approach to quality governance, to ensure its governance arrangements are robust and meet the requirements set by our regulatory bodies and commissioners. As such the post holder will support the Trusts ambition of being and outstanding provider of health care. Do you have excellent communication skills, experience in governance and assurance, managing multiple teams and, adept at identifying learning from patient safety incidents, clinical negligence claims, and other sources?

Job Posting Job Description

Are you naturally curious? So are we at MKS. Our collective curiosity drives us to be an innovation leader in many industries. Our products drive technology advancements across a wide range of applications such as 5G, augmented/virtual reality, autonomous vehicles, clean drinking water and space exploration. We are a team of collaborators who value fresh thinking and believe in mutual respect, constructive candor, diversity and inclusion. As a valued and trusted partner to our customers, we are continually pushing the boundaries of possibility. We believe in creating technology that transforms our world and are looking for like-minded individuals to join our team. If this is appealing to you, we want to meet you.

We are looking for an exceptional Senior Quality Engineer (EE) who can…

• Support NPI transfer and Production readiness activities that includes new or existing products from Design Engineering to Manufacturing.
• Create and submit Engineering Change Orders (ECO’s), Manufacturing Change Orders (MCO’s) for PCBA’s and electro-mechanical assemblies.
• Interpret requirements for EE PCBA testing and utilize industry best known methods.
• Work closely with US test development teams to develop reliable test collateral (fixtures and methods) then transfer to Asia based supplier to ensure effective test coverage & yield performance metrics are achieved.
• Develop, review, and approve engineering/test/supplier documentation to assure that appropriate quality and operational requirements are addressed.
• Develop and drive proposed solutions to address PCBA / EE related failures that may impact production.
• Collaborate directly with EMS suppliers as well as Design Engineering to resolve design issues that result in risk to the Quality & Reliability.
• Develop and engage suppliers in the areas of preventative action, corrective action, and continuous improvement to eliminate recurrence.
• Partner with design engineering to facilitate supplier value engineering in product development with strong influence in DFT & Quality improvements.
• Demonstrate expertise in Lean Manufacturing principles and establish manufacturing test methods, processes, and tools to streamline new and existing products.
• Support production issues and effective process control systems for on-going manufacturing of products.
• Lead & drive First article inspections for the PCBA’s, Cables & electro-mechanical assemblies.
• Analyze Field returns/failure rate to improve product performance and determine root cause with a focus on overall Yield improvements.

What will you bring to the team, along with your curiosity and creativity is:

• Bachelor’s / Master’s degree in Electrical Engineering or related disciplines and a minimum 7+ years of relevant industry experience.
• Experience with PCBA manufacturing including box build assemblies, SMT process and Testing methods.
• Proficient in interpreting schematics and hands-on troubleshooting electronic circuits.
• Demonstrated use of Quality tools/methodologies such as: SPC, GR&R, Poke-yoke, FMEA, PFMEA, CAPA, 8D as well as production processes for electronics (IPC600, IPC610, IPC620).
• Ability to drive production escalations and interact with internal team and external suppliers to influence decisions, provide direction, and develop solutions.
• Proficiency in Microsoft Visual Studio programming in Visual Basic or C# preferred.
• Experience in Python and deploy data collection (mySQL or MSSQL databases) will be an added advantage.
• Good team player who is self-motivated, independent and has ability to exercise judgement in complex situations.

At Thales, we know technology has the ability to make our world more secure, sustainable, and inclusive ? and that it?s all driven by human intelligence.

Because it takes human intelligence to build and power the systems and solutions that people depend on every day. So we stay curious and make space for diverse points of view. We share what we know and we challenge what?s possible.

From manufacturing and engineering to cybersecurity and space, we?re driving progress in some of the world?s most important industries ? and working together to build a future we can all trust.

OUR BENEFITS

Competitive remuneration + Super + Profit Share
ThalesFlex ? Hybrid work environment
Fitness Passport Discount ? Access to a network of Gyms across AUS as cheap as $14.95 P/W
Employee discounts with a number of affiliates (Travel, Car hire, Tech, Medical Insurance)
Modernised Paid Parental Leave
Veterans Leave
Novated Lease ... Click here to view more detail / apply for Senior Quality Coordinator ? High Explosives

GetGo is Singapore’s largest and fastest-growing carsharing platform that enables everyone with the freedom to drive without the burden of ownership. Our vision is to be APAC’s #1 carsharing platform as we seek to create a mobility ecosystem that's shared and sustainable for all.

You will be part of the GetGo Fleet Quality Team to oversee and manage GetGo’s fleet, partner workshops, and insurance-related matters. You will collaborate closely with our affiliated workshops and insurance providers to oversee fleet quality and delivery schedules, ensuring the delivery of the highest fleet quality to our users. You will also support the Trust & Safety (User Trust) team with quotations on accidents and damages.

Day to Day Activities

• Assess damages on GetGo vehicles and work closely with internal teams for any subsequent actions to be taken
• Manage and follow-up with affiliated workshops to monitor and ensure smooth delivery of GetGo vehicles in a timely manner
• Collaborate with various teams including but not limited to our Fleet Operations, Trust & Safety and Finance teams for issues pertaining to Fleet Quality
• Liaise with insurers pertaining to insurance matters such as accident reporting, investigation, and repudiation issues
• Generate quotations for accidents and damages to our fleet based on photographs provided by customers and our internal teams

Who We Are Looking For

• Minimum two (2) years of experience in either workshop or motor insurance environment within the automotive industry
• Ability to assess and prepare estimated accident and damage repair quotations preferred
• Excellent communication and interpersonal skills
• Familiar and comfortable working with MS Excel/Google Sheets

Why You Should Join Us

• Be part of the fastest growing and largest carsharing technology company in Singapore
• Achieve meaningful objectives as part of a mission-driven and values-based organisation
• An opportunity to experience an open, inclusive, and culture-first work environment

Strong personal alignment with our GetGo Values:

• Driven by Purpose
• Stay Curious and Humble
• Collaborate with Empathy
• Make it Better
• Get It Going!

Industry: Food, Medical/Healthcare, Pharmaceutical/Clinical Research/BioTech

Location: Central (Near MRT Station)

Position: QC cum Lab Executive (Job ID: 19008)

Working hour: Mon - Fri, 08:30～17:30

Job Description:

- Perform QC tests on facilities, raw materials, semi-finished product and finished product
- Perform quality tests according to relevant industrial standards
- Maintain Lab equipment and facilities to be compliance to regulations
- Maintain sufficient Lab consumable supplies
- Maintain periodical records of all tests and measurements
- Inspect, test and evaluate incoming raw materials for production
- Ad-hoc lab test instructed by management
- Familiar with ISO and GMP compliance
- Creating, managing and maintaining various compliance document including SOPs
- Training planning and execution for operators (GMP training, hygiene management, and work procedures)
- Implement of GMP internal audits

Job Requirements:

- Degree or Diploma, preferably Chemical related topics
- Hands-on Labs tests experience required
- Min 2-3 years of relevant work experience
- Able to travel overseas in the future (mainly in Japan and ASEAN countries)

We regret that only shortlisted candidates will be notified. Other applications will be updated to our database for future job opportunities.

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Lee Xin Hui

EA Registration No: R22108046
Pasona Singapore Pte Ltd
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EA License No:90C4069