Amazing opportunity with one of our Global Bio-Pharmaceutical company in the German speaking part of Switzerland looking for CQV Doc Preparation.
Responsibilities:
- Commissioning, Qualification and Validation Projects (CQV)
- Generation and Execution of CQV Documentation:
- Validation Plan, Test Strategy, User requirement specifications (URS)
- Impact/Risk/FMEA, Design Qualification (DQ) documents, IQ/OQ/PQ
- Installation Qualification, Operational Qualification, Performance Qualification, Requirement Traceability Matrix, Test Reports and Final Validation Reports
- Review of commissioning documentation (e.g. Factory Acceptance tests, Site Acceptance Tests, Installation verification
- cGMP Review
- GDP Review
- Design Review
- Test and Validation Reports
Candidate profile:
- Education: Bachelor's degree or higher in Engineering (Mechanical / Plant Engineering or similar)
- Minimum of 5+ years of experience in commissioning / qualification / validation (DQ, IQ, OQ, Commissioning) activities in the pharmaceutical/biotech industry
- Fluent English language written and verbal communication skills
- cGMP knowledge and knowledge of regulatory requirements.
- Able to work with minimum oversight fulfilling deliverables within target dates
- Fluent German is a distinct preference
- Experience with COMOS/KNEAT platforms
For further information about this position please apply
*Please note, only those with the right to work in Switzerland can apply!
(Unfortunately we do not sponsor work visa)
