Job description
Experience: Typically 8–15 years
- Job Purpose The QC Manager is responsible for overseeing all quality control activities related to raw materials, in-process materials, and finished medical devices to ensure compliance with regulatory standards, GMP, and internal quality systems.
Key Responsibilities
Quality Control Operations 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. Documentation & Compliance 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. Quality Systems Monitor calibration, validation, testing, and inspection activities. Ensure quality requirements are met during production and process control. Support CAPA (Corrective and Preventive Action) implementation.
Investigation & Troubleshooting 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. Team Management Lead and supervise QC analysts and officers. Provide training on SOPs, testing methods, and compliance procedures.
Coordinate with QA, Production, and Regulatory teams. Key Skills Quality systems management Laboratory operations CAPA & deviation management Regulatory compliance Documentation & audit readiness Team leadership Good laboratory practices, sample panel preparation, QC lab process set up, method validations, training, performance studies Requirements ISO 13485, GLP, IVDR, WHO Required Qualifications 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 Please fill in the following Form https://forms.zohopublic.in/merillifesciencespvtltd688/form/Quality.
Control. Manager. Candidate. Application/formperma/zm_7oaQR_GN7VmlgGH4xsU1Tsi_cAOU-sI4NhYTkxn0