We are looking for an enthusiastic and motivated colleague who will help us to strengthen our QA team of Janssen Biologics, somebody who would like to contribute to a high quality organization of the site and J&J. The main focus will be warehouse related quality issues, but can vary over time.
The QA associate will be the linking pin in the investigations into quality issues 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 is various teams.
About the Company: 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 in Leiden is currently manufacturing COVID 19 vaccine (Drug Substance) vaccine. 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. The QA department plays an important role in providing advice on quality topics to all departments of the supply chain.
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 & the 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, analytical technical transfer
- Act as member in Quality Risk Management and /or root cause investigation sessions.
We would love to hear from YOU, if you have the following essential requirements
- BSc in bioscience, chemistry, pharmacy or related subject with 4 years of experience.
- Msc in bioscience, chemistry, pharmacy or related subject with 2 years of experience.
- Good communicative, collaboration and advisory skills in both Dutch and English, both (verbal and written)
- Up to date knowledge of GMP regulations
- Preferably Quality Assurance experience in pharmaceutical or related industry
- Experience with quality investigations, root cause problem solving and quality risk management
- Familiarity with PE, LEAN tools, concepts and methodologies is preferable.
This is what awaits YOU at J&J: This is an opportunity to work with a highly motivated team and to be a member of a Johnson & Johnson company, with an excellent record in employee continuous professional development and business improvement. We are passionate about our work; we play vital roles across a range of professional subject areas and care deeply about our customers and communities. At Johnson & Johnson our culture enables dynamic and impactful careers. Whether you’re one of the ~1000 people who work here, or you’re considering joining the team, we offer:
- Flexible working hours
- Your chance to work for a global market leader.
- A dynamic and inspiring working environment.
- Opportunities to work on exciting projects and assignments