QA Expert Drug Product.

We are looking for a QA Engineer at our client's (Merck) site in Aubonne for 12 months for: :

- Ensure that semi-finished products and diluents, manufactured internally or externally, for market meet the appropriate quality requirements and are in compliance with current Good Manufacturing Practices (cGMP’s), any applicable regulatory filings and Merck Quality Standards. 
- Manage the change control request and ensure that semi-finished products and diluents delivered on the market are in compliance with the Regulatory Constraints.
- Review the Manufacturing Batch Records / documentation and recommend the release of semi-finished products and diluents manufactured externally and at Aubonne.

Your missons:

Release
• To perform usage decision of commercial semi-finished products and diluents manufactured at Aubonne or externally manufactured after documentation review.
• To edit Certificate of Analysis of commercial semi-finished products and diluents manufactured at Aubonne.
• To review and close out investigations with regard to deviation and ensure that preventive and/or corrective actions are implemented as appropriate.

GMP-Compliance
• To review and approve manufacturing procedures and documentation associated to the manufacture of semi-finished products and diluents (e.g. Procedures, Modèles de production, Master Batch Record…) 
• To take part into internal audits and auto-inspections.
• To contribute to Customer complaints investigation.

Change control
• To evaluate and approve all manufacturing change requests and ensure that semi-finished product and diluents delivered on the market are in compliance with the Regulatory Constraints.

Monitoring and validation
• To sign-off Validation Plan, User Requirements Specifications (URS), Performance Qualification protocols and reports, validation protocols and reports concerning FDF Manufacturing Unit 
• To review the documentation relative to Aseptic Process Simulation, Smoke test studies and maintenance operations during the shut-down and approved the relative reports.

Regulatory and Health Authority inspections
• To provide answers to technical requests coming from the Quality Unit Regulatory Affairs.
• To contribute to Health Authority Inspections

Your profile: 

•    University degree with minimum 3 years of experience in Pharmaceutical industry, with preference in Aseptic filling industry.
•    Experience in Quality Assurance.
•    Fluent in French and in English
•    Primordial : Purposeful, Results-driven, and Collaborative. Important : Future-oriented, Innovative, and Empowering.