Senior Manager

• Manage QC testing of raw materials, in-process samples, and finished products.

• Ensure compliance with GMP, GLP, ISO standards, and regulatory guidelines.

• Review and approve QC test results and batch release documentation.

• Maintain and improve laboratory systems and testing procedures.

• Ensure QC documentation, SOPs, and records are properly maintained and updated.

• Review and approve change control, deviation reports, and investigation reports.

• Maintain laboratory compliance with regulatory audits and inspections.

• Monitor calibration, validation, testing, and inspection activities.

• Ensure quality requirements are met during production and process control.

• Support CAPA (Corrective and Preventive Action) implementation.

• Investigate OOS (Out of Specification) and OOT (Out of Trend) results.

• Identify root causes and implement corrective actions.

• Ensure product quality is maintained throughout manufacturing.

• Lead and supervise QC analysts and officers.

• Provide training on SOPs, testing methods, and compliance procedures.

• Coordinate with QA, Production, and Regulatory teams.

• Quality systems management

• Laboratory operations

• CAPA & deviation management

• Regulatory compliance

• Documentation & audit readiness

• Team leadership

• B.Sc / M.Sc / B.Pharm / M.Pharm or related science field

• 8–15 years experience in QC in pharma or medical devices

• Knowledge of

• GMP / GLP

• ISO 13485

• Regulatory compliance (CDSCO / FDA / CE)

• Analytical instruments and lab systems

Meril