We are seeking a skilled C&Q Specialist to lead commissioning and qualification activities for QC laboratory systems, equipment, and support utilities. This role ensures compliance with GMP standards and regulatory requirements while supporting cross-functional teams and external vendors.
Key Responsibilities:
* Act as SME for QC laboratory C&Q scope.
* Plan, coordinate, and execute commissioning and qualification for lab systems (e.g., analytical instruments, HVAC, water systems).
* Develop and review protocols (IQ/OQ/PQ), validation plans, and reports.
* Coordinate with CSV and global IT teams.
* Identify and resolve risks, troubleshoot issues, and implement corrective actions.
* Maintain and report C&Q status to stakeholders.
Candidate Profile:
* Bachelor’s degree in Life Sciences or Engineering.
* 5+ years of CQV experience in a GMP environment.
* Proficiency with laboratory instruments (e.g., HPLC, GC, UV-Vis) and CSV for lab systems.
* Strong knowledge of IQ/OQ/PQ processes and regulatory standards (FDA, EMA, ISO).
* Experience with Kneat for CQV execution is an advantage.
* Excellent communication skills and cGMP knowledge.
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