Qualification / Validation Engineer – Life Sciences (FR)
Alten
- Waadt
- Unbefristet
- Vollzeit
- Qualification phases are performed according to global and local company policies and procedures as well as legal requirements and requirements set by regulatory authorities.
- Qualification Master plans are up to date and established for all ongoing projects.
- Plan, coordinate and execute all phases for qualification of GMP manufacturing systems including but not limited to, Qualification plans, FMEA, DQ, IQ, OQ, PQ.
- Prepare, review and approve technical and GMP related documentation (URS, impact/risk assessment, Master plans, qualification documentation).
- Coordinate and execute FAT/SAT, commissioning activities for new manufacturing systems in collaboration with internal and external partners.
- Coordination and oversight of external suppliers.
- Must have : GMP knowledge
- Must have : Master’s degree in pharmaceutical or biotech related industries.
- Above 5 years of experience in qualification and validation
- Languages: English, French and/or German
- On-site work in cities: Geneva, Lausanne, Schaffhausen, Bern, Basel, Neuchâtel.