Head - Quality Control

Job Description Head, Quality Control

Location: OSD Matoda

The Head of Quality Control is responsible for the overall leadership, governance, compliance, and efficient operation of the Quality Control laboratories at OSD Matoda. The role ensures that all laboratory activities are performed in accordance with applicable cGMP, GLP, regulatory requirements, approved procedures, and organizational quality standards.

Key responsibilities include:

1. Ensure effective implementation of cGMP, GLP, data-integrity requirements, and approved quality systems across all QC laboratory activities.
2. Provide overall oversight of testing and release activities for raw materials, packaging materials, in-process samples, finished products, stability samples, and other applicable materials.
3. Review and approve QC documents, including specifications, standard testing procedures, general testing procedures, SOPs, analytical method-transfer protocols/reports, validation documents, and Certificates of Analysis.
4. Ensure timely execution and implementation of analytical method transfers, method verification/validation, compendial updates, and regulatory filing commitments.
5. Ensure laboratory investigations, including OOS, OOT, atypical results, deviations, CAPAs, and complaints, are scientifically sound, thoroughly documented, and completed within established timelines.
6. Provide QC support for process validation, cleaning validation, stability studies, regulatory submissions, production schedules, product investigations, and customer requirements.
7. Ensure laboratory instruments and equipment are appropriately qualified, calibrated, maintained, and available to support business and testing requirements.
8. Lead regulatory inspections and customer audits for QC-related areas, respond to observations and queries, and ensure timely implementation of commitments and corrective actions.
9. Establish laboratory capacity, resource, and succession plans; recruit, train, mentor, and develop QC personnel to maintain high technical and compliance standards.
10. Monitor laboratory performance through suitable quality, compliance, productivity, investigation, and turnaround-time indicators, and initiate improvements where required.
11. Prepare and manage the QC annual operating and capital expenditure budgets, including procurement and lifecycle management of laboratory instruments and equipment.
12. Monitor changes in pharmacopoeias, regulatory guidance, and scientific literature and ensure timely assessment and implementation of applicable requirements.
13. Promote continuous improvement, operational excellence, digitalization, right-first-time performance, and a strong quality and data-integrity culture within the laboratory.
14. Collaborate with Quality Assurance, Manufacturing, Regulatory Affairs, R&D, Supply Chain, Engineering, and other functions to achieve site and organizational objectives.
15. Define the QC organizational structure, assign responsibilities, establish performance objectives, conduct performance evaluations, and maintain effective communication within the department.
16. Participate as a member of the site Quality Operations leadership team and perform any additional responsibilities assigned by senior management.

interested candidate can share CV at :

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