Senior Officer, Quality Control

The Executive – Quality Control is responsible for ensuring smooth laboratory operations in compliance with cGMP, GLP, and regulatory requirements. The role includes handling analytical activities, reviewing raw data, maintaining laboratory documentation, instrument calibration and maintenance, LIMS management, and release of COA. The candidate should coordinate investigations related to OOS, OOT, deviations, incidents, and CAPA, while ensuring timely closure and compliance. The position also requires training analysts, maintaining quality systems, supporting audits, and ensuring proper implementation of SOPs and laboratory procedures.

This role demands strong analytical knowledge, documentation skills, instrument handling experience, and expertise in Quality Control systems and LIMS.

Key Responsibilities:

• Follow and maintain cGMP, GLP, safety norms, and company policies.
• Ensure implementation and compliance of SOPs, STPs, GTPs, and laboratory procedures.
• Review completed raw data and release Certificate of Analysis (COA).
• Maintain all QC laboratory documentation, records, and online raw data monitoring.
• Review and monitor calibration schedules for all laboratory instruments.
• Handle laboratory incidents, deviations, OOS, OOT, and CAPA closure within timelines.
• Coordinate investigations related to analytical incidents and deviations.
• Preparation, review, and updation of SOPs, protocols, test plans, and stability documents.
• Manage LIMS activities including master creation, review, troubleshooting, and user training.
• Registration and management of reference standards, working standards, instruments, and columns in LIMS.
• Conduct analyst training on current updates, LIMS processes, and laboratory practices.
• Support qualification activities for LIMS modules and analytical instruments.
• Ensure monthly electronic data verification and backup data verification.
• Monitor analyst evaluations and laboratory performance.
• Undertake any other responsibilities assigned by QC Head / Department Head.

Required Skills:

• Strong knowledge of Quality Control laboratory operations.
• Experience in handling analytical instruments and maintenance activities.
• Good knowledge of LIMS management and troubleshooting.
• Expertise in handling deviations, CAPA, OOS, OOT, incidents, and investigations.
• Strong documentation and review skills.
• Good communication, training, and team coordination skills.
• Knowledge of regulatory requirements including USFDA, WHO, MHRA, and GMP guidelines.