We are looking for an experienced QC Manager to lead and oversee the complete Quality Control function, ensuring compliance with cGMP, applicable regulatory requirements, internal SOPs and Quality Management Systems (QMS).
Key Responsibilities
Ensure compliance with cGMP and applicable regulatory requirements across QC operations.
Ensure availability, implementation and compliance of approved SOPs for QC and laboratory activities.
Review and approve/reject Raw Materials, Packaging Materials, Intermediates, Bulk and Finished Products.
Ensure completion and review of all required testing and analytical records before batch release.
Review and approve COAs for Raw Materials, Packaging Materials, Intermediates and Finished Products.
Lead and review investigations related to OOS, OOE, OOC, Lab Incidents and Deviations.
Monitor and ensure effective implementation of CAPA and QMS activities.
Review and approve RM, PM, Stability, In-process and Finished Goods specifications.
Review and approve stability protocols, reports and stability data.
Review trend data related to water testing and environmental monitoring.
Ensure compliance and coordination with the Microbiology department.
Ensure data integrity of manually and electronically generated laboratory data.
Ensure proper qualification of QC analysts and maintain qualification records.
Plan and ensure completion of training and on-the-job training for QC personnel.
Ensure timely completion of instrument calibration, qualification and validation.
Ensure proper maintenance, storage and control of standards, reagents, columns and laboratory samples.
Conduct and participate in internal, external, vendor and contract laboratory audits.
Review and monitor testing conducted through external/contract testing laboratories.
Support regulatory/customer inspections and ensure timely response to inspection observations.
Review and approve packing material artwork from the QC perspective.
Ensure proper retention and maintenance of analytical documents and control samples.
Provide necessary QC data and support for Product Quality Review (PQR).
Coordinate procurement of chemicals, glassware and laboratory consumables.
Coordinate AMC/CMC activities for QC instruments.
Ensure proper laboratory cleaning, housekeeping and maintenance.
Prepare and manage QC CAPEX and departmental budgets.
Drive better utilization of manpower, instruments and other QC resources.
Lead the QC team and ensure smooth functioning and productivity of the entire Quality Control department.
Review outside laboratory reports and prepare test requests for external laboratory testing.
Ensure overall readiness of the QC department for GMP audits and regulatory inspections.
Candidate Profile
5–15 years of relevant experience in Quality Control, preferably in Pharma, Nutraceutical, API, Formulations or a similar GMP-regulated manufacturing environment.
Strong hands-on experience in QC laboratory operations and team management.
Strong knowledge of cGMP, QMS, OOS/OOE/OOC, Deviations and CAPA.
Experience in batch release, analytical data review, COA approval and stability studies.
Experience in internal, external, vendor and contract laboratory audits.
Knowledge of data integrity, analyst qualification, instrument calibration and validation.
Strong documentation, analytical, problem-solving and cross-functional coordination skills.
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