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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 reporting of 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.
Requirements:
- Bachelor’s degree in Life Sciences or Engineering
- 5+ years of commissioning, qualification, or validation experience in a GMP environment in a Life Sciences relevant discipline
- Familiarity with laboratory instruments such as HPLC, GC, UV-Vis spectrophotometers, and other analytical equipment.
- Experience with computer systems validation (CSV) for laboratory systems.
- Previous experience in authoring CQV lifecycle documents necessary
- Strong knowledge of qualification and validation processes for laboratory systems and equipment
- Experience in the preparation and review of IQ/OQ/PQ protocols and reports
- Experience using Kneat for CQV test execution
- Fluent English language written and verbal communication skills.
- cGMP knowledge and knowledge of regulatory requirements.
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