- Sky project (165 million Swiss Francs investment). Construction of a new facility at existing Aubonne site to increase the production capacity as of 2023.
Position & key responsibilities
- Issuance, review and approval of GMP documentation (Quality Risk Assessment, Qualification & Validation Protocols and Reports, URS, Specifications, Quality Agreement, Deviations, Change Control, CAPA, VMP, VP and SOPs
- Quality referent for Equipment Process Project
- Ensuring compliance and adherence to Merck’ standards, Quality Manual,registration files and regulatory requirements