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C&Q Engineer

Key information

  • Publication date:11 December 2024
  • Workload:100%
  • Contract type:Temporary
  • Language:English (Fluent)
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

Lucie Nasshan

Contact

  • Randstad (Schweiz) AG