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About the Role
Job Description
Job Responsibilities
- Maintain and oversee the Quality Management System in laboratories, including execution of investigations into laboratory errors and quality issues, determination of root causes, and implementation of appropriate CAPAs.
- Monitor laboratory events (LIR and OOS) and ensure compliance with relevant KPIs including cycle time optimisation, reduction in laboratory incidents, and minimisation of out-of-specification results due to laboratory error.
- Manage the change control process for laboratory operations, ensuring all modifications are governed through the appropriate CCM procedure and aligned with current pharmacopeial and regulatory requirements.
- Oversee qualification, calibration, and maintenance of laboratory instruments, minimising downtime whilst maintaining comprehensive documentation and records.
- Manage laboratory licensing, vendor agreements, and quality agreements to ensure effective operat...
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