Role Objective
A key objective of this position is to lead and govern the Quality function at the manufacturing site, ensuring uncompromised product quality, patient safety, and compliance with global regulatory requirements (USFDA, EU-GMP, MHRA, WHO-GMP, TGA, and other regulated markets) across sterile injectable operations. The role is responsible for building a robust Quality Management System, driving a robust quality culture, ensuring inspection readiness, and enabling business continuity through consistent, compliant, and right-first-time manufacturing and testing of injectable products.

Desired Candidate Profile

B.Pharm / M.Pharm / M.Sc. (Chemistry or Microbiology) or equivalent; a Ph.D. or additional certification in Quality/Regulatory Affairs will be an added advantage.
18–22 years of progressive experience in Quality Assurance/Quality Control, with a mandatory and demonstrable background in pharma injectable (sterile/parenteral) manufacturing – vials, ampoules, PFS, lyophilized products, or biologics.




Prior experience of successfully hosting and clearing regulatory inspections (USFDA, EU-GMP, MHRA, WHO, ANVISA, etc.) at an injectable facility.
Proven track record in leading site quality operations for a large-scale, high-volume sterile manufacturing plant.
Strong exposure to aseptic processing, isolator/RABS technology, media fill validation, and environmental monitoring programs.
Demonstrated leadership in managing large, multi-level quality teams (QA, QC, Microbiology, Validation, Regulatory Compliance).
Excellent stakeholder management skills with the ability to interface with regulators, corporate quality, and site leadership.

Roles & Responsibilities:

Provide strategic leadership to the site Quality function (QA, QC, Microbiology, Validation, and Documentation) in line with corporate quality objectives.
Own and drive the site Quality Management System (QMS), ensuring alignment with global GMP/GDP standards.
Set annual quality objectives, KPIs, and

📌 General Manager Quality (Rajkot)
🏢 Biotech Healthcare
📍 Rajkot