For our client, an international pharma company in Kaiseraugst, we are looking for a Qualification and CSV Expert to support qualification of embedded systems.
General Information:
- Start date: ASAP
- Planned duration: 2 years
- Extension: likely
- Contract: temporary contract via Randstad
- Workplace: Kaiseraugst
- Workload: 100%
- Home Office: up to 20%
- Working hours: Standard
Tasks & Responsibilities:
- Implementation and documentation of qualification processes for our embedded systems / process automation systems according to cGMP.
- Development, implementation, and execution of test strategies, test plans, and test cases to verify system performance and compliance.
- Technical participation in the creation of specifications (e.g., URS)
- Collaboration with the IT, Process Engineering/Automation, Quality Assurance, and Production departments to ensure smooth integration and qualification of systems.
- Creation and maintenance of qualification documentation (DQ, IQ, OQ, PQ) and supporting design documents such as data flow diagrams and audit trail review assessments.
- Processing of qualification impact assessments as part of change or deviation process management.
- A proactive and self-reflective approach to working in expert teams.
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