C&Q Engineer
CK QLS are recruiting for a C&Q Engineer to join an important project with a global Pharmaceutical Company at their site based in Bern on a contract basis until the end of the year.
The main purpose of the role will be to:
- Plan, coordinate andexecute 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
In order to be considered for this role, you willbe required to have the following qualifications, skills and experience:
- Bachelor/Master Degree in technical or natural sciences
- Working experience within pharmaceuticals, biotechnologies or chemical industry
- Know-how of commissioning and qualification requirements according to (c)GMP regulations
- Know-how of quality assurance principles and experience working with cross-department stakeholders
- Experienced with GAMP5: Risk-based Approach to Compliant GxP Computerized Systems
- Know-how of ISPE baseline guide vol 3, vol 4 and vol 5 is a plus
- Equipment knowledge:
- Profile 1
- QPCR, Wireless glove tester, HPLC and N2 generator, Tecan, Nexgen, Endoscan
- Profile 2
- Waage und Titrator
- Biosafety cabinets
- Climate chambers, hot air sterilizer, fridge, freezer, incubator
- Nanodrop
For more information or to apply for this position, please contact Adrien on 0041 (0) 800 106 106 or email aguimard@ckqls.ch. Please could you send any correspondence in English. Please quote reference 50688 in all correspondence.
