Total 2 job vacancies by 3563 MSD International GmbH

Job Description

A fantastic opportunity has arisen for a QC Systems Associate Director, this is a key site leadership position within the QC department, where you will be responsible for providing vision, leadership and direction for the QC Systems team.

This position carries the remit and accountability to enable the site to bring the very best of innovation to the oncology patients of the world who are counting on us to deliver.The role ensures that the QC team objectives are effectively achieved, consistent with our company's requirements to ensure compliance, safety and reliable supply to our customers. The successful candidate will bring energy, knowledge, leadership, and innovation to carry out the following:

What you will do:

• Creates a diverse and inclusive culture that excels in safety, quality and delivers on the strategic vision for Biotech Dublin QC as a paperless tech enabled Laboratory.
• Supports the QC Laboratory through QC Systems and equipment installation, qualification, operation, and retirement.
• Leads continuous improvement of QC operations, through their QC Systems knowledge and areas of expertise.
• Purchase, install, qualify, build, maintain, and integrate QC Systems, as required, including divisional systems, instrumentation, and their software or equipment, in compliance with up-to-date data integrity, regulatory, and industry standards.
• Author, review and approve technical documents, standard operating procedures, deviations, investigations, change management related to QC Systems.
• Lead project management to meet established QC Systems delivery timelines.
• Oversight and management of the Stability Program at the site.
• Implementing stability strategies for new and licensed products and ensuring oversight of execution of stability protocols as per the overall stability strategy.
• Work cross-functionally with our company's internal sites and global partners to successfully implement Technology Enabled Labs (TEL) capability within the QC department
• Define and lead the change management process and mechanisms required to maintain QC Systems in a validated state throughout their lifecycle.
• Troubleshoot divisional systems, instrumentation and their associated software or equipment as subject matter expert (SME).
• Lead, coach and mentor the QC Systems team. Build diverse talent with the capabilities necessary to succeed in commercial drug substance manufacture. Develop team members through supporting their continued personal and professional career growth.
• Assisting in and facilitating investigations (leading where required), ensuring effective Root Cause Analysis and CAPAs.
• Represent the QC department as a QC Systems SME for internal audits/regulatory inspections and support permanent inspection readiness.
• Escalate potential cGMP or compliance issues effectively in a timely manner for proper resolution to ensure product quality.
• Inspire Diversity and Inclusion by building effective working relationship with cross-functional teams across different cultures and backgrounds.
• Drive and own metrics that appropriately and accurately measure QC performance and take action to mitigate as required.
• Support various site functional and cross functional tier structures.

• Be an advocate for continuous improvement, new technologies and innovation. Lead and foster an environment of continuous improvement through deployment of Model Lab and management systems across the lab operations.
• Trouble-shoot laboratory process and equipment issues as needed.
• Actively participate in Site/Quality committees and works with other site functional groups to help set direction for GMP and continuous improvement initiatives.

What skills you will need:

To excel in this role, you will more than likely have:

• Degree (or higher) in Chemistry, Biology, Microbiology, Engineering or in a relevant discipline, the successful candidate will also have significant exposure in delivering operational excellence in GMP environment
• This role requires a seasoned professional with the expertise (10 to 15 years) with at least 5 years in a leading position and attributes that will ensure success in this highly accountable role.
• Working knowledge in the biotech industry is required with specific understanding of QC operations, regulatory agency engagement and ability to gain alignment on strategy.
• The successful candidate should have the knowledge and ability to mentor the QC systems implemented at the site.
• Strong stakeholder management skills and proven experience dealing with above site groups, particularly for divisional systems
• Demonstrated ability to manage multiple priorities against ambitious timelines.
• Strong problem-solving skills and ability to work cross-functionally as critical member of site team
• Hands-on application of lean tools and techniques: standardized work, scientific problem solving, value stream mapping, capacity analysis.
• Coaching, teaching, and driving a High-Performance Organization. Proven experience in coaching and teaching others to think, behave and apply lean methods and tools. Experience enabling and leveraging diverse perspectives, talents, etc. to achieve business outcomes.

As a company, we are dedicated to 'Inventing for Life' in all that we do. We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world's most challenging healthcare needs.

As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. Please don't hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process.

We are dedicated to flexible working where possible, and therefore our Company has introduced a new hybrid working model for office-based colleagues around the world. Please feel free to speak to us about what flexibility means to you during your application or click on the link to find out more about our hybrid working model

So, if you are ready to:

Invent solutions to meet unmet healthcare needs, please apply today.

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Description

An amazing opportunity has arisen for a QC Bioanalytical Associate Specialist at our Biotech Dublin site. The role will report to the QC Manager & Associate Director.
 

What you will do:

Bring energy, knowledge, innovation and leadership to carry out the following:

• Executing and Supporting routine analytical testing with assays such as HPLC Analysis (IEX, SEC, RPLC), UV analysis, Capillary Electrophoresis and a wide range of compendial methods on Release, In-process, Raw Materials and Stability samples.
• Support technical writing tasks such as deviation, protocol, report and procedure authorisation.
• Participate and lead continuous improvement and laboratory transformation projects.
• Support GMP, EHS and audits on site.
• Maintain good housekeeping and hygiene within the laboratory.  
• Calibrate and maintain all designated laboratory instruments.  
• Follow up-to-date practices with reference to pharmacopoeias, specifications, regulations and industry standards.  
• Ensure training is current for all job functions performed.  
• Maintain data integrity and ensure compliance with company SOPs, specifications and cGMP regulations.  
• Ensure that cGMP standards are maintained at all times.  
• Promote and participate the implementation and maintenance of the relevant safety programmes.  
• Maintain MPS/Lean Lab standards within the laboratory. 
• Support with various QC related Initiatives. 

What skills you will need:

In order to excel in this role, you will need:

• A bachelor’s degree (or higher) in Natural Science/Chemical Engineering/Biological Engineering 
• Minimum 2 years’ experience in the Pharmaceutical industry. 
• Experience in performing Laboratory testing. 
• Experience in Technical writing.
• Project participation and leading experience.
• Working knowledge of Six Sigma and Lean methodologies. 
• Knowledge of GMP practices (Experience in GMP facility is a bonus!) 
• Good understanding of relevant Analytical testing. 

As a company, we are committed to 'Inventing for Life' in all that we do. We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world's most challenging healthcare needs.

As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. Please don't hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process.

So, if you are ready to:

Invent solutions to meet unmet healthcare needs, please apply today.

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):