QA Regulatory Compliance
Brabant Walloon – contracting
Our partner is looking for a QA Regulatory Compliance to join its team. This international company is well-known for its pharmaceuticals.
Your responsibilities?
- You will ensure as quality representative, compliance to regulatory dossier of activities related to Manufacturing Performance Units or Quality Control Department
- You provide Chemistry/Manufacturing/Controls (CMC) and regulatory expertise within Manufacturing Performance Units or Quality Control Department, to ensure continuous alignment of Operations with the approved data by Health Authorities.
- You support Manufacturing Performance Units or Quality Control Department for CMC processes
- You oversee Change Control
- You support MPU/QC head and QA head by being the Single Point of Contact (SPOC) for any decision related to regulatory compliance.
- You are responsible for coaching and developing regulatory awareness of Manufacturing Performance Units or Quality Control Department.
- You are responsible for coaching and developing awareness of MPU/SPU shop floor practices to GRA team.
- 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.
- You are empowered to take decision in grey area for regulatory topics.
Your profile?
- Minimum 7 years in Pharmaceutical Industry (preferably in an FDA approved context) including minimum 5 years in Regulatory
- GMP knowledge
- 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, sharing of good practices within the network)
- Strong quality and results oriented mindset
Our offer?
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. We will be your career partner for each step along the way. You’re interested in this job? We kindly invite you to apply. Do you have any questions? You can contact Anaïs Malikian, [email protected]
