QC Manager

2 days ago


Baddi, Himachal Pradesh, India Mediwell Biotech Full time ₹ 1,00,00,000 - ₹ 1,50,00,000 per year

Key Responsibilities

  1. Laboratory Operations

  2. Manage QC laboratory activities for raw materials, intermediates, finished products, and stability samples.

  3. Review and approve analytical reports, COAs, and test data.
  4. Ensure calibration and maintenance of instruments like HPLC, GC, UV, FTIR, Dissolution Apparatus, etc.
  5. Implement proper documentation as per 21 CFR Part 11, WHO-GMP, and GLP norms.

  6. Compliance & Quality Systems

  7. Ensure compliance with DCGI, State FDA, WHO, and export regulatory requirements.

  8. Review and maintain SOPs, STPs, and Specifications for all materials and products.
  9. Handle OOS, OOT, deviations, and CAPA investigations.
  10. Support internal and external audits and regulatory inspections.

  11. Team Leadership

  12. Supervise and train QC analysts, chemists, and microbiologists.

  13. Allocate daily testing work and monitor laboratory productivity.
  14. Conduct competency evaluation and skill enhancement sessions.

  15. Documentation & Reporting

  16. Approve analytical results and maintain batch-wise QC release records.

  17. Manage retention samples, stability studies, and trending reports.
  18. Oversee documentation control as per data integrity principles (ALCOA+).

  19. Cross-Functional Coordination

  20. Coordinate with QA for batch release and market complaints.

  21. Collaborate with Production for in-process controls and process validations.
  22. Work with Procurement for vendor qualification of raw materials and packaging materials.

Qualifications:

  • Education: M.Pharm / B.Pharm / M.Sc (Chemistry / Microbiology)
  • Experience: Minimum 8–12 years in QC (pharmaceutical formulations), with at least 3 years in a managerial/supervisory role.

Knowledge Required:

  • HPLC, GC, UV, dissolution, and other analytical techniques
  • WHO-GMP, ICH, and GLP guidelines
  • Stability studies, LIMS, and data integrity

Job Types: Full-time, Permanent

Pay: ₹60, ₹90,000.00 per month

Work Location: In person


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