Quality Assurance Specialist

vor 1 Tag


Basel, Basel-Stadt, Schweiz CTC Resourcing Solutions Vollzeit

CTC Resourcing Solutions is a specialist industry expert in talent sourcing, HR, and consulting services. We are working with a leading CDMO company located in the Basel area to find a Quality Assurance Specialist for a 12 months contract initially.

About the Role:

The Quality Assurance Specialist will play a crucial role in supporting the setup, qualification, validation, and maintenance of laboratory environments.

Key Responsibilities:
  1. C&Q SME for QC Laboratory scope
  2. Plan, coordinate, and execute commissioning and qualification activities for QC laboratory systems, equipment, and support utilities as needed (e.g., analytical instruments, laboratory systems, HVAC, and water systems)
  3. Coordination of execution activities with supporting CSV Team and global IT teams
  4. Lead C&Q testing activities supported by external vendors and/or contractors
  5. Develop any supporting validation plans related to scope of execution
  6. Develop and review Qualification Protocols (IQ/OQ/PQ), commissioning documents, and final reports, ensuring compliance with relevant standards (GxP, FDA, EMA, ISO, etc.)
  7. Support the updates of Master C&Q Plan and supporting plans during project execution lifecycle
  8. Maintain and report C&Q status to the C&Q Lead, which can be reported into project stakeholders meetings (e.g., Tier 1 meetings, Wall meetings)
  9. Generate, review, approve, CQV test scripts in accordance with Verification Plans and any applicable site commissioning or validation plans or procedures
  10. Identify potential risks or issues during commissioning and qualification activities and lead troubleshooting efforts when necessary. Implement corrective actions as needed
  11. Assist the C&Q Lead with the Handover and Release process


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