Quality Assurance Specialist
Veröffentlicht:
04 Oktober 2024Pensum:
100%Vertrag:
Festanstellung- Arbeitsort:Leiden
- This position will be based at our Leiden site.
- Initially a 12-month fixed-term contract, with the intention to extend.
Change lives for the better.
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.
THE OPPORTUNITY
The department Quality Assurance ensures that quality systems are applied as per GMP standards within J&J Innovative Medicine and is responsible for handling non-conformances, bulk product and intermediate product release and change control. The QA department plays an important role in providing advice on quality topics to all departments of the supply chain.
The QA associate will be the linking pin in the investigations into Non-Conformances and with that responsible for the improvement of the overall quality status.
The activities are very dynamic and varied. The candidate likes challenges, doesn’t avoid problems and enjoys working in various teams.
To fill in this phenomenal new opportunity, we are looking for an enthusiastic and driven colleague who can take up this challenging role as QA Associate.
The responsibilities & impact YOU will have:
- 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.
- Assist 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 executed in a controlled and systematic manner conform cGMP and regulatory requirements e.g. but not limited to stability, validation.
- Act as member in Quality Risk Management and /or root cause investigation sessions.