For our Techfirm Industrial Services team, we would like to integrate a QA Qualification Engineer (M/W/D) ready to join us in Basel to take up new challenges together!
The role will provide Quality oversight on both systems and execution of commissioning and qualification, cleaning and process validation and approving respecting documents.
Responsibilities
* Ensures as QA representative the Quality compliance of all elements (e.g. URS, QRA) leading to commissioning and qualification activities (DQ, IQ, OQ and PQ).
* Review and approve C&Q system specific documentation URS, RTM, QRA, IOC – if applicable, IQ, OQ, PQ, QR according to internal standards.
* Assess and review Punches and Project Deviations occurred on assigned Systems during C&Q Phase.
* Assess and review Deviations and Changes occurred during initial validation activities in the Start-Up Phase.
* Establish Guidance Documents (SOPs, WIs etc) based on request covering Commissioning and Qualification Cleaning and Process Validation.
Qualifications
* GMP knowledge and knowledge of regulatory requirements.
* Good technical understanding of pharma or biotech processes.
* Qualification and Validation experience at a minimum of 3 years in a similar role, preferably gained in Pharma or Biotech.
* Several years (at a minimum 3 years) of successful commissioning and/or qualification experience on mid-sized and major projects with high complexity in the chemical, biotech or pharmaceutical industry.
* Proven experience in GMP environment, Commissioning & Qualification as well as Cleaning and Process Validation and Quality Risk Management.
* Language: Fluent in English and German, French is an advantage.
If you are interested in joining us, (no need for a motivation letter).
Please note, that we can only consider Swiss or EU/EFTA nationals or applicants with a valid residence or work permit for Switzerland.
Seniority Level
Mid-Senior level
Employment Type
Part-time
Job Function
Engineering and Information Technology
Industries
Engineering Services and Pharmaceutical Manufacturing
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