Assistant Manager

Position summary

QC operations and supervision

• Plan, prioritize and allocate daily QC activities based on production requirements and sample priorities.
• Supervise routine analysis of raw materials, intermediates, in-process samples, finished APIs and stability samples, as applicable.
• Ensure timely testing, documentation and reporting; monitor workload, turnaround time and team performance.
• Ensure availability and proper use of instruments, chemicals, reagents and reference standards.
• Lead QC analysts and laboratory personnel, assign responsibilities, monitor performance and ensure adherence to approved SOPs.
• Train staff on analytical methods, laboratory safety, GMP practices and documentation; coordinate with Production, QA, R&D and other departments.
• Support shift planning and effective resource utilization, where applicable.

Instrument troubleshooting and quality systems

• Troubleshoot HPLC and GC issues, analytical failures, abnormal chromatograms, system suitability failures and instrument performance issues.
• Coordinate corrective maintenance and ensure instrument calibration, qualification, maintenance and usage documentation.
• Comply with GMP requirements, approved SOPs and internal quality procedures; review QC records, analytical data, logbooks and test reports.
• Participate in deviation management, CAPA, change control and other QMS activities; uphold data integrity and good documentation practices.
• Support internal and customer audits and regulatory inspections.

Investigations and improvement

• Lead or support OOS/OOT investigations, analytical discrepancy reviews, laboratory incident investigations and unexpected result assessments.
• Perform systematic root cause analysis, recommend corrective and preventive actions, document investigations and complete them within defined timelines.
• Track CAPA implementation and verify effectiveness, as applicable.
• Ensure compliance with GMP, GLP, pharmacopoeial and regulatory requirements; maintain housekeeping, safety and laboratory standards.
• Identify improvements to laboratory efficiency, analytical reliability and documentation quality and support continuous improvement initiatives.

Mandatory requirements

• M.Sc. in Chemistry.
• 8–10 years of pharmaceutical Quality Control experience, including mandatory API QC experience.
• Proven work planning, laboratory supervision and team handling experience.
• Hands-on knowledge of HPLC and GC troubleshooting.
• Strong understanding of QMS and pharmaceutical quality systems.
• Experience in OOS/OOT investigations and root cause analysis.
• Good knowledge of GMP, laboratory documentation, data integrity and regulatory compliance.

Preferred skills

• Experience in API manufacturing and analytical testing of pharmaceutical intermediates and finished APIs.
• Knowledge of analytical method validation and method transfer.
• Familiarity with CAPA, deviations, change control and risk assessment.
• Leadership, problem-solving, communication and decision-making skills.