- Interact with Internal Quality Assurance Managers and External Manufactures to perform batch record review and complete release packages for global markets.
- Evaluate batch manufacturing records, deviations, and associated CAPA plans and identify issues which may impact the quality of the product or the compliance to marketing authorizations.
- Independently resolve minor issues
- Consult with the account manager as needed for resolution of major issues
- Ensure that all relevant QA related concerns at external manufacturing sites are raised to Janssen management.
- Ensure Janssen specific manufacturing operations external manufacturing sites are executed in a compliant manner
- Proactively identify risks and potential issues and delays in market release, and where possible, drive resolution.
- Extensive (> 3 y) knowledge of GMP, specifically parenteral experience is preferred (QA and/or production)
- Able to connect easily, team worker, able to manage across cultures
- A minimum of 8 years working in an FDA or similar regulated environment; Quality Assurance experience preferred
- A minimum of 5 years’ experience working with pharmaceutical GMPs, specifically biopharmaceutical experience is preferred (QA and/or production)
- Able to build connections with stakeholders, and manage across cultures
- Strong interpersonal and written/oral communication skills
- Proficient in applying process excellence tools and methodologies
- Startdate: 01-02-2023 (flexible)
- Duration: until end of year, with chance of extension
- Travel: 25%
- Language: English mandatory, other languages are a benefit
If you are interested in the above description, please apply with your CV. For more information, please contact Merel van Os on +31 (0)20 20 44 502 or by e-mail at firstname.lastname@example.org