Imagine your next project supporting the integrity of analytical development and production compliance within Advanced Therapeutics at Johnson & Johnson Innovative Medicine.
We are looking for someone motivated who enjoys working in a multidisciplinary environment with different stakeholders.
Responsibilities- Review document revisions
- Lead document revisions
- Manage Change Controls
- Process non-conformance/CAPA records
- Having close contact with stakeholders
- Manage training curricula of AD employees
- Perform self inspections within the department
- Design and implement improvements regarding quality and compliance
- MLO-4 or HBO
- Experience with cGMP
- Affinity and experience with (laboratory) systems such as COMET, TruVault, and SUMMIT.
- 2-5 years of work experience with compliance management related activities.
- Developed interpersonal skills and able to build strong relationships.
- Experience working in a Quality driven environment.
- Good communication in English and Dutch (written and verbally).
- Accurate, pro-active, a team player and capable of building good relations with all stakeholders.
- Discount on the collective health insurance scheme via Zilveren Kruis
- Access to the YACHT network of companies and industry specialists
- A favorable pension scheme (STIPP)
- 8 % holiday allowance
- Good travel allowance of €0.23 per km up to 26 km one way
- Training budget provided by Yacht: €3,500 per year
- A one-time home office allowance of €750
- Soft skills coaching
At Johnson & Johnson Innovative Medicine, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure diseases inspires us. We bring together the best minds and pursue the most promising science.
Johnson & Johnson Innovative Medicine is recruiting for an Associate Scientist, Advanced Therapeutics, Analytical Development, located in Leiden, The Netherlands.
Department:
The Strategic Operations (SO) group is part of the Analytical Development (AD) Department of the Advanced Therapeutics AD sector of J&J Innovative medicine.
The SO group focuses on supporting production and laboratory activities with:
- Assuring compliance to GMP standard.
- Execution of all internal release, stability and PAS testing.
- Maintaining controlled state of the production clean room and production utilities by environmental and utility monitoring programs and performing safety testing on our products.
- Inspection, release and change management of incoming production raw materials, laboratory chemicals and Lab supplies.
- Sample and Material receipt, handling, storage and forwarding.
- Cell Culture services where cells are maintained used for assays and production cell line quality is supported.
- Coordination of Release and Stability testing and Outsource testing.
- Managing the data systems, equipment and automation solutions in the AD labs
Voor meer informatie neem contact op met Nicole Miggels 06-13897074
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#J-18808-Ljbffr€45000 - €65000 monthly