General Manager Quality Control

5 hours ago

Bengaluru, Karnataka, India Sami Sabinsa Group Full time

  1. Quality Control Leadership

  2. Lead and manage end-to-end QC operations covering raw materials, in-process, finished products, stability studies, and microbiological testing.

  3. Establish and implement QC strategies aligned with business goals, regulatory requirements, and global quality standards.

  4. Ensure timely release of materials and finished goods without compromising quality.

  5. Regulatory Compliance & Audits

  6. Ensure compliance with FSSAI regulations, Schedule IV GMP, USFDA 21 CFR Part 111, and applicable international standards.

  7. Lead and manage regulatory inspections, customer audits, and third-party audits related to QC.

  8. Review and approve responses to audit observations, deviations, OOS/OOT, CAPA, and change controls.

  9. Analytical & Laboratory Excellence

  10. Approve analytical methods, method validation/verification, and method transfer activities.

  11. Oversee calibration, qualification (IQ/OQ/PQ), and maintenance of QC instruments and laboratory infrastructure.

  12. Ensure integrity and accuracy of laboratory data in line with ALCOA+ principles.

  13. Stability & Product Quality Management

  14. Oversee stability programs as per ICH guidelines and nutraceutical regulatory requirements.

  15. Ensure scientifically sound shelf-life assignment and trend analysis.

  16. Monitor product quality trends and initiate continuous improvement actions.

  17. Documentation & Quality Systems

  18. Ensure preparation, review, and approval of SOPs, specifications, STPs, COAs, and quality reports.

  19. Strengthen documentation practices, data governance, and electronic systems (LIMS, CDS, ERP).

  20. Ensure compliance with data integrity and record retention requirements.

  21. Team Leadership & Capability Building

  22. Build, mentor, and develop a high-performing QC team.

  23. Drive training programs on GMP, GLP, data integrity, and regulatory compliance.

  24. Conduct performance reviews and succession planning for QC leadership.

  25. Cross-Functional & Business Support

  26. Collaborate with QA, R&D, Production, Regulatory Affairs, Procurement, and Supply Chain teams.

  27. Provide QC inputs for new product development, scale-up, technology transfer, and vendor qualification.

  28. Support regulatory submissions, export registrations, and customer technical requirements.

  29. Continuous Improvement & Cost Optimization

  30. Drive laboratory efficiency, right-first-time testing, and reduction in OOS/OOT trends.

  31. Implement automation, digitization, and best practices in QC operations.
  32. Optimize laboratory costs without compromising quality or compliance.

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