Head - Quality Control

Stanford Laboratories; Nimera; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Stanford Laboratories seeks a QC Lead for its OSD manufacturing facility to oversee chemical analysis, microbiology and analytical laboratory operations, ensuring timely testing and release of materials and finished products.

The role drives cGMP/GLP compliance, method development and validation, OOS/OOT handling, stability studies, data integrity and audits, while mentoring the QC team and coordinating with QA, Production and Regulatory.

Responsibilities

• Lead the QC function for the OSD manufacturing facility, covering chemical analysis, microbiology and analytical laboratory operations, as applicable.
• Ensure testing and release of Raw Materials, Packaging Materials, In-process, Finished Products and Stability samples within defined timelines and approved specifications.
• Ensure compliance with cGMP, GLP, pharmacopoeial requirements and applicable regulatory guidelines for all QC laboratory activities.
• Lead analytical method development, method validation/verification, method transfer and analytical procedure implementation as per approved protocols.
• Manage OOS, OOT, deviations, laboratory incidents and investigations, ensuring effective root-cause analysis, CAPA and timely closure.
• Oversee stability studies, including preparation of protocols, sample analysis, data review and timely reporting in accordance with regulatory requirements.
• Ensure effective management of laboratory instruments and equipment, including qualification, calibration, preventive maintenance and timely resolution of breakdowns.
• Ensure proper management of reference standards, impurities, working standards, chemicals, reagents, solvents and laboratory consumables, including inventory and expiry control.
• Review and approve analytical reports, specifications, COAs, test methods, protocols, SOPs, specifications and other QC documents as per the applicable approval matrix.
• Ensure data integrity and ALCOA+ compliance, including proper control of analytical data, electronic systems, chromatographic data and laboratory records.
• Lead preparation and effective response to regulatory inspections, customer audits and internal audits, and ensure timely implementation and closure of observations/CAPA.
• Develop and mentor the QC team, establish competency requirements, conduct training and ensure adequate manpower and laboratory resources to support plant operations.
• Coordinate closely with QA, Production, R&D, Regulatory, Engineering, Stores and other functions for timely resolution of quality and analytical issues.
• Drive continuous improvement in QC processes, laboratory efficiency, turnaround time, compliance and cost optimization while maintaining quality standards.

Job description

Role & responsibilities

1. Lead the QC function for the OSD manufacturing facility, covering chemical analysis, microbiology and analytical laboratory operations, as applicable.
2. Ensure testing and release of Raw Materials, Packaging Materials, In-process, Finished Products and Stability samples within defined timelines and approved specifications.
3. Ensure compliance with cGMP, GLP, pharmacopoeial requirements and applicable regulatory guidelines for all QC laboratory activities.
4. Lead analytical method development, method validation/verification, method transfer and analytical procedure implementation as per approved protocols.
5. Manage OOS, OOT, deviations, laboratory incidents and investigations, ensuring effective root-cause analysis, CAPA and timely closure.
6. Oversee stability studies, including preparation of protocols, sample analysis, data review and timely reporting in accordance with regulatory requirements.
7. Ensure effective management of laboratory instruments and equipment, including qualification, calibration, preventive maintenance and timely resolution of breakdowns.
8. Ensure proper management of reference standards, impurities, working standards, chemicals, reagents, solvents and laboratory consumables, including inventory and expiry control.
9. Review and approve analytical reports, specifications, COAs, test methods, protocols, SOPs, specifications and other QC documents as per the applicable approval matrix.
10. Ensure data integrity and ALCOA+ compliance, including proper control of analytical data, electronic systems, chromatographic data and laboratory records.
11. Lead preparation and effective response to regulatory inspections, customer audits and internal audits, and ensure timely implementation and closure of observations/CAPA.
12. Develop and mentor the QC team, establish competency requirements, conduct training and ensure adequate manpower and laboratory resources to support plant operations.
13. Coordinate closely with QA, Production, R&D, Regulatory, Engineering, Stores and other functions for timely resolution of quality and analytical issues.
14. Drive continuous improvement in QC processes, laboratory efficiency, turnaround time, compliance and cost optimization while maintaining quality standards.