QLS are recruiting for a C&Q Engineer to join a project with a Global Pharmaceutical Company based in Bern on a contract basis for 10 months.
The position will report to the C&Q Manger and is in charge of Commissioning & Qualification (C&Q) activities for Technical Services department in order to ensure that:
- Qualification/Validation phases are performed according to global and local company policies and procedures as well as legal requirements and requirements set by regulatory authorities
- Qualification/Validation Master plans are up to date and established for all ongoing projects
- Write/review Qualification/Validation plans, including but not limited to DQ, IQ, OQ, PQ plans/protocols and final reports for new or modified GMP utilities, facilities, and process equipment · Execution of DQ, IQ, OQ, PQ, including protocol deviations, investigation, and corrective action activities for new or modified GMP utilities, facilities, and process equipment
- Plan and track execution of Commissioning & Qualification activities/documentation versus project(s) timeline
- Prepare, review and approve technical and GMP related documentation (URS, FMEA, impact/risk assessment, Master plans, qualification/validation documentation)
- Coordinate and execute FAT/SAT, commissioning activities for new GMP systems in collaboration with internal and external partners · Coordination and oversight of external suppliers
- Bachelor/Master?s degree in technical or natural sciences
- A minimum of 3 years of working experience within pharma company in C&Q/CQV equivalent position
- Know-how of Qualification requirements according to cGMP regulations
- Experience working with cross-department stakeholders · Know-how of quality assurance principles · Experience working in project teams and multiple projects in parallel
- Experience working with 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
- German language is a plus
- Self-time management
Please could you send any correspondence in English. Please quote job reference 54122 in all correspondence.
You must have the right to work in Switzerland.
- Agency: CK Group
- Reference: 54122
Website: CK Group
- Posted: 25th July 2022
- Expires: 22nd August 2022