Beschreibung
Key facts:Start Date: ASAP Duration: 6 months (extension possible) Workload: 100 % Location: Canton Bern
Project information:
You perform qualification and validation activities for a bio pharmaceutical product
Responsibilities:
- Performing Validation/Qualification phases according to global and local company policies and procedures as well as legal requirements and requirements set by regulatory authorities
- Performing Qualification Master plans
- Planning, coordinating and executing validation/qualification of equipment and computer system validation including impact/risk assessment regarding DQ, IQ, OQ
- Preparing, reviewing and approving technical and GMP related documentation. Especially URS
- Coordinating and executing FAT/SAT
- Coordinating of external qualification partners
- Operational handling of Change Controls, CAPAs and Non-Conformances related to process equipment and cleaning
Qualifications:
- B.Sc. / M.Sc. preferably in engineering
- Minimum 3 Years of experience in Pharma/Biotech
- Know-how of biotechnology processes
- Qualification/Validation experience (cGMP)
- Fluent in English and German
Sounds interesting?Please send me your CV or contact me for further information
Sthree Switzerland is acting as an Employment Business in relation to this vacancy.