Senior Officer, Quality Control

About the role

The Executive – Quality Control ensures smooth laboratory operations in compliance with cGMP, GLP, and regulatory requirements. The role involves analytical activities, data review, instrument calibration, LIMS management, and release of Certificates of Analysis.

Key responsibilities

• Maintain cGMP, GLP, safety norms and company policies.
• Implement and enforce SOPs, STPs, GTPs, and laboratory procedures.
• Review raw data and release Certificates of Analysis (COA).
• Manage QC documentation, records, and online raw data monitoring.
• Oversee calibration schedules for all laboratory instruments.
• Handle laboratory incidents, deviations, OOS, OOT and ensure timely CAPA closure.
• Coordinate investigations related to analytical incidents and deviations.
• Prepare, review and update SOPs, protocols, test plans and stability documents.
• Administer LIMS activities, including master creation, troubleshooting and user training.
• Support qualification activities for LIMS modules and analytical instruments.

Required profile

• Master’s degree in Chemistry (M.Sc.).
• Minimum 7 years of experience in Quality Control laboratory environments.
• Strong knowledge of USFDA, WHO, MHRA and GMP regulatory requirements.

Required skills

• Quality Control laboratory operations.
• Analytical instrument handling and maintenance.
• LIMS management and troubleshooting.
• Deviation, CAPA, OOS and OOT investigation.
• Regulatory compliance (USFDA, WHO, MHRA, GMP).