Sr. QA Associate
Janssen Biologics B.V. - Leiden (Nederland)
For our client, Janssen Biologics B.V., we are looking for a Sr. QA Associate .
The QA department plays a meaningful role in providing advice on quality topics to all departments of the supply chain. In addition, together with a multidisciplinary team, you play a crucial role in the introduction of new modalities to the site.
As Sr. QA associate, you will be the linking pin in the investigations into quality issues and, with that, responsible for the improvement of the overall quality status of new products. You will work in close collaboration with other departments (Operations, Pilot Plant, QC labs, MAM and Technical Operations). The activities are very dynamic and varied. Do you like challenges, enjoy working in various teams and solving problems? Then we are looking for you!
- Be the lead contact for departments they work with;
- Quality Owner for commercial products;
- Ensure that, in a timely manner, a clear and quality prospected advice is given to all cGMP and/or quality related issues encountered during (non)routine operations. Lead all aspects of site investigations and ensure that all CAPAs are implemented and effective within agreed timelines;
- Raise serious quality, compliance and /or GMP incidents to Site or Global Management;
- Setup and co-ordinate Site and Global critical issue meetings;
- Act as quality specialist and participate in the preparations for and during inspections (FDA, EMA etc.) to accomplish a successful audit;
- Perform level assessment, review and approval of (deviation related) change controls;
- Partner with site colleagues to ensure all site changes and projects are conducted in a compliance to cGMP and company quality requirements;
- Assess, review and approve study protocols and reports to assure that studies will be completed in a controlled and systematic manner conform cGMP and regulatory requirements e.g. but not limited to stability, validation, analytical technical transfer;
- Act as member in Quality Risk Management and /or root cause investigation sessions.
Who we're looking for
The ideal candidate has an M.Sc. in a science related subject with 3-5 years of QA experience within pharmaceutical industry. You are familiar with PE. LEAN tools concepts and methodologies. Furthermore, you are fluent in English and you have excellent interpersonal skills.
Are you the experienced QA Associate we are looking for?
Janssen Biologics B.V. is a multinational pharmaceutical company that has been for more than 25 years a leader in the field of biomedicines. Through the dynamic science of biotechnology, we continue to seek innovative ways to treat cancer, infectious diseases, cardiovascular and metabolic diseases, and immune-mediated inflammatory disorders (I.M.I.D.s), such as rheumatoid arthritis and psoriasis. Janssen Biologics is part of the Johnson & Johnson family of companies.
The department Quality Assurance sees to that quality systems are applied as per GMP standards within Janssen Biologics and is responsible for handling non-conformances, bulk (PFB / FB) and intermediate (DPC / CSS) release and change control.
Additional vacancy information
|Contract||:||Direct contract with client|
|Employment terms||:||32-40 hours/week|
3 days/week on site in Leiden
|Location||:||View location with Google Maps|
|+31 (0)88 22 77 555|
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