C&Q Engineer

Vor 2 Tagen


Bern, Schweiz Randstad Vollzeit
Jobdescription For our client, an international company based in Bern, we are looking for a C&Q Engineer. General Information:

Start date: ASAP, latest in January 2025 Contract duration: 1 year with possibility of extension Workplace: Bern Workload: 100% Home office: possible up to 2 days per week Tasks and Responsibilities:

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: (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 Qualifications and Skills: Bachelor/Master’s degree in technical or natural sciences Working experience within pharma/Medical Devices companies Practical experience in a C&Q role is a must Know-how of Qualification requirements according to cGMP regulations Know-how of thermal mapping studies Know-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
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