TAPI
TAPI

Senior Manager Quality Control

TLDR

Elevate quality standards and operational excellence in a high-impact pharmaceutical environment with compliance expertise and regulatory readiness.

🚨 We’re looking for a vigilant Quality Control & Compliance Senior Manager with strong expertise in regulatory systems, laboratory management, and audit readiness. If you excel in implementing SOPs, driving ICH/cGMP compliance, managing QC operations, and ensuring seamless regulatory inspections, this opportunity to elevate quality standards and operational excellence in a high‑impact pharmaceutical environment is for you.

Main Responsibilities:

  1. Implementation of Procedure supporting the quality control SOP’S and Corporate SOP’S.
  2. Review and approval of specification of RM/FP/STP/SOP. Review and approval of Protocol/Reports.
  3. Ensuring and organizing Professional / regulatory training of QC Lab employees.
  4. Involving in the OOS and deviations from QC, QA and Production. Ensuring the investigation on OOT & boarder line results.
  5. Signing on approved column in data books, laboratory control card and signing on the COA of final material and signing on hard copies as well as approval (release) in LIMS.
  6. Implementing quality system with respect to regulatory ICH & CGMP requirement.
  7. Handling of customers queries and regulatory inspections. Supporting DMF’S w.r.t required documents from QC.
  8. Manpower evaluation in the lab as per Projections and allotment of jobs to team members timely. Monitoring of productivity of people and timeliness of Laboratory activities like releases and schedules.
  9. 24 × 7 audit readiness.
  10. Budget management of Capital and Revenue w.r.t QC as per the needs
  11. Ensuring the Annual maintenance and calibrations for all equipment in the   QC Lab
  12. Ensuring software qualification and their CSV
  13. Ensuring the environmental, water samples analysis w.r.t chemical and microbiology as per schedules
  14. Ensuring all the analysis in laboratory including cleaning w.r.t production planning
  15. Gases (utilities) sampling and analysis as per requirement
  16. Ensuring standard /chemical reagent management and their qualification based on requirement
  17. Ensuring third party operation and their qualification
  18. Ensuring the Proper site transfers or method transfer to QC
  19. Ensuring method verification and validation based on requirement
  20. Facility up gradation w.r.t QC wherever required
  21. Supporting Corporate Quality Management as and when required
  22. Ensuring the implementation of Pharmacopeias updates.

The ideal candidate will have: 

  • Education: M.Sc. in Chemistry.

  • Experience: Minimum 12 years of industrial experience.

  • Preferred Industries: API / Pharma.

  • Good understanding of Quality control, Understanding of GXP

Make Your Mark with TAPI

Your journey with TAPI is more than a job—it’s an opportunity to make a lasting impact on global health. If you’re ready to lead, innovate, and inspire, we’re excited to welcome you to our team. Together, let’s shape the future of pharmaceuticals. Apply on top of this page and our talent acquisition team will be in touch soon!

TAPI is a global leader in the production and supply of active pharmaceutical ingredients (APIs), partnering with 80% of the top 50 pharmaceutical companies worldwide. With a strong portfolio of over 350 products and custom CDMO services, TAPI is dedicated to advancing health through innovation and collaboration across its 13 state-of-the-art facilities globally.

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