A Fantastic new role has just opened up at one of our leading Swiss based clients offering the successful candidate the opportunity to join a hard-working team working on exciting projects in the pharmaceutical sector.
- In charge of commissioning and qualification (C&Q) activities for Technical Services department in order to ensure that:
- Qualification/Validation Master plans are up to date and established for all ongoing projects in QC
- Plan, coordinate and execute all phases for qualification of GMP manufacturing systems including but not limited to, Qualification/Validation plans, FMEA, DQ, IQ, OQ, PQ.
- Prepare, review and approve technical and GMP related documentation (URS, impact/risk assessment, Master plans, qualification/validation 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
- Operational handling of Change Controls, CAPAs and Non-Conformances related to qualification topics
Skills and Requirements
- Bachelor/Master Degree in technical or natural sciences
- A minimum of 3 years of working experience within pharma company in C&Q equivalent position
- Know-how of Commissioning and Qualification requirements according to cGMP regulations and international guidelines
- Know-how of ISPE baseline guide vol 3, vol 4 and vol 5 is a plus
- Excellent communication skills
- Analytical thinking and problem-solving ability
- Business fluency in English
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.