Posted: 13 Feb 2024
Are you passionate about the pharmaceutical world? And highly open to join an international team in the development of solutions to help people to have a good life?
If your answers are yes, this great opportunity is for you ;)
Tasks and responsibilities:
The position will report to the C&Q Manger and is in charge of Commissioning & Qualification (C&Q) activities for the Technical Services department in order to ensure that:
- (re-) qualification of production/QC equipment including thermal mapping studies are performed according to global and local company policies and procedures as well as legal requirements and requirements set by regulatory authorities
- Commissioning & Qualification Master plans are up to date and established for all ongoing projects.
- Write/review Commissioning & Qualification plans and reports.
- Execution of RQ, IQ, OQ, PQ, including protocol deviations, investigation, and corrective action activities
- Plan and track execution of Commissioning & Qualification activities/documentation versus project(s) timelines
- Prepare, review and approve technical and GMP related documentation (URS, FMEA, impact/risk assessment, Master plans, qualification/validation documentation)
- Coordinate and execute commissioning & qualification activities in collaboration with internal and external partners
- Coordination and oversight of external suppliers
- Bachelor/Master’s degree in technical or natural sciences
- Working experience within pharma/Medical Devices companies
- K-how of Qualification requirements according to cGMP regulations
- K-how of thermal mapping studies
- K-how of quality assurance principles
- Excellent communication skills
- Analytical thinking and problem-solving ability
- Business fluency in English. German language is a plus
- Self time management
We thank you for your application :)