Job Description

Job Responsibilities

1. 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.
2. 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.
3. 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.
4. Oversee qualification, calibration, and maintenance of laboratory instruments, minimising downtime whilst maintaining comprehensive documentation and records.
5. Manage laboratory licensing, vendor agreements, and quality agreements to ensure effective operational partnerships and compliance.
6. Supervise wet chemistry, stability, and microbiology teams to support timely analysis of finished products, intermediates, and raw materials whilst meeting site KPIs and business expectations.
7.



Conduct audit management activities, respond to audit observations and customer queries, and track compliance report completion for internal and external audits.
8. Develop and deliver training programmes to ensure laboratory personnel are adequately qualified for their roles, maintain training records, and identify overdue or periodic training requirements.
9. Promote a quality culture within the laboratory, establish data integrity awareness, and implement appropriate controls to prevent data integrity issues.
10. Ensure compliance with local and global EHS KPIs, conduct safety-related GEMBA walks, and maintain availability of trained emergency response and first aid personnel across all shifts. Qualifications

Experience Level: 13-18 Years
Industry Experience: API Experience is required
Qualification: M.Sc. in Chemistry

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