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.
Darwin Recruitment AG is a Zurich based, SECO licensed, privately owned subsidiary of Darwin Professional Staffing Group Ltd (a Global IT Recruitment Consultancy).
Darwin Recruitment AG manages client relationships whilst also utilising Darwin Professional Staffing Group databases and networks to source Candidates and fulfil client requests.
We do not ask for a placement fee from Candidates/Employees.
If you wish to contact a specialist regarding this role, or your job search in general, please contact +41 (0)43 456 29 09
Greg King