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Gmp Compliance
Il y a 3 mois
Location:
Wavre
#22053
GMP Compliance:
Wavre - contracting
Our partner is looking for a
QA Regulatory Compliance to join its team. This international company is well-known for its pharmaceuticals and vaccines.
What are your responsibilities ?:
- Review and/or approval of variations/submissions/RTQ/Commitment + provide technical support to GRA
- You support Manufacturing Performance Units or Quality Control Department for CMC processes
- On quality oversight of source documents and providing operational documents to support GRA in authoring post approval changes' variations
- Review, on behalf of Operations, submitted documents to Health Authorities in the frame of Regulatory Submission Process.
- Support Questions & Answers and Commitments process within Manufacturing Performance Units or Quality Control Department.
- You oversee Change Control
- You provide technical support to Global Regulatory Affairs (GRA) in communication to and from Health Authorities in the frame of post approval changes management.
- You provide CMC and regulatory conformance expertise to support release of products in compliance with marketing authorization through deviation assessment, visibility to registered details, post approval changes guidance.
Let's talk about you :
- A scientific background
- A knowledge of legislation related to license acquiring and post approval changes management
- A knowledge of the CMC dossier and GMP
- Technical understanding of product manufacturing processes and/or testing
- Good knowledge in English
- Sense of urgency, flexibility and accountability Enterprise thinking (cross functional team spirit)
- Strong quality and results oriented mindset, Assertive, Lean culture spirit
Preferred Qualifications:
- If you have the following characteristics it would be a plus:
- Demonstrated ability to quickly understand end to end process
- Demonstrated ability to take full accountability of small or medium project
- Good analytical and problemsolving skills
What can you expect?:
Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills.
You're interested in this job? We kindly invite you to apply. Do you have any questions? You can contact
**Marie Rossenfosse
