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.
Within the Compliance Management team the following tasks are included but are not limited to:
- - 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
Functie-eisen
- 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.
Competenties
- 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.
Arbeidsvoorwaarden
- 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
Bedrijfsinformatie
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
Contactinformatie
Voor meer informatie neem contact op met Nicole Miggels 06-13897074
Een baan via Yacht Engineering
Yacht is dé organisatie van en voor professionals. Wij verbinden professionals en organisaties die het verschil willen maken. Ons doel is optimaal resultaat: jou als professional uitdagend werk bieden waarmee jij de organisaties van onze opdrachtgevers blijvend verbetert. Behoor jij tot de beste professionals in jouw vak? Wil je samen met vakgenoten het verschil maken bij toonaangevende organisaties? We geloven dat diverse teams van belang zijn voor ons als lerende organisatie die voorop wil blijven lopen in de wereld van werk. Want juist verschillen tussen mensen zorgen voor groei. Van collega's, klanten, kandidaten en daarmee van Yacht. Heb jij een uniek talent? We ontmoeten je graag!
Uiteraard staat deze vacature open voor iedereen die zich hierin herkent.
contact
Nicole Miggels
nicole.miggels@yacht.nl
06-13897074
Zo verloopt het solliciteren via Randstad Professional | Yacht. Ontdek hoe we jou kunnen helpen om een baan te vinden.
Je sollicitatie en cv worden doorgenomen door Nicole Miggels
Binnen 5 werkdagen ontvang je een reactie
Is er een match, dan plannen we een persoonlijke kennismaking
We onderzoeken samen jouw ambitie en mogelijkheden
Daarna word je (eventueel) voorgesteld bij onze opdrachtgever
Wanneer de klik er is, ga je starten bij je nieuwe uitdaging!
Afhankelijk van het soort dienstverband (interim, zzp of vast), ontvang je van ons een aanbod
