Quality Assurance Specialist
vor 1 Tag
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:- C&Q SME for QC Laboratory scope
- 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)
- Coordination of execution activities with supporting CSV Team and global IT teams
- Lead C&Q testing activities supported by external vendors and/or contractors
- Develop any supporting validation plans related to scope of execution
- Develop and review Qualification Protocols (IQ/OQ/PQ), commissioning documents, and final reports, ensuring compliance with relevant standards (GxP, FDA, EMA, ISO, etc.)
- Support the updates of Master C&Q Plan and supporting plans during project execution lifecycle
- 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)
- Generate, review, approve, CQV test scripts in accordance with Verification Plans and any applicable site commissioning or validation plans or procedures
- Identify potential risks or issues during commissioning and qualification activities and lead troubleshooting efforts when necessary. Implement corrective actions as needed
- Assist the C&Q Lead with the Handover and Release process
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