Qualification: M.Sc / B. Pharm
Experience: 12+ Years

Key Responsibilities:

• Review and prepare SOPs, calibration procedures, specifications, and test methods.
• Conduct training on specifications, analysis methods, SOPs, and calibration procedures.
• Handle and ensure timely closure of QMS documents (Change Control, CAPA, OOS, deviations, etc.).
• Investigate laboratory errors/incidents and their impact on quality.
• Collaborate with cross-functional teams on QMS-related investigations.
• Ensure adherence to Good Laboratory Practices.
• Prepare/review schedules for stability, hold time, preventive maintenance, and calibration.
• Coordinate with external calibration agencies and review instrument qualification data.
• Work with other departments to ensure smooth laboratory operations.
• Oversee the approval of analysis-related documents (TRF, GRN, stability samples).
• Ensure training of staff as per job requirements and attend CGMP training.
• Participate in method validation, transfer, and verification activities.
• Ensure compliance with health, safety, and environmental norms.
• Support audits (customer, regulatory, internal) and maintain good housekeeping practices.
• Report daily activities to the Manager – QC in the absence of Sr. Manager