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Manager External Quality, Large Molecule EMEA
Description
Work at Janssen Supply Group as a support manager for External Quality at the FDBD site.
Responsible for providing support to the account manager through review of batch and validation documentation, assessment of deviation investigation, CAPAs and change requests, completion of release packages and management of routine issues to ensure the highest levels of quality and compliance for Janssen Biologics products.
Specific Objectives:-
· Knowledge of the requirements for the production and release of Biologics products in the EU and associated countries, and in-depth knowledge of deviation management processes.
· A minimum of 5 years working in an FDA or similar regulated environment; Quality Assurance experience preferred.
· A minimum of 3 years experience working with pharmaceutical GMPs, specifically biopharmaceutical experience is preferred (QA and/or production).
· Strong interpersonal and written/oral communication skills.
· Proficient in applying process excellence tools and methodologies.
Effective Date
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Qualifications
We invite you to join our Global Talent Hub, where we keep in touch with people around the world who share our passions for bold innovations and are inspired by our mission of changing the trajectory of human health.
Functie: | external quality manager |
Startdatum: | 06-12-2023 |
Ervaring: | Ervaren |
Educatielevel: | HBO |
Contracttype: | Vast |
Salaris: | onbekend – onbekend |
Uren per week: | 1 – 40 |
Heb je interesse in deze vacature en wil je graag op deze functie solliciteren? Neem dan contact op met Unknown via Unknown of Unknown. Of bezoek hun website Unknown.
Deel de vacature:
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