Job Description

Senior Specialist- Quality & Compliance

Our Company's Manufacturing Division, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that's committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.

Responsible for providing functional support for Analytical Standards and Analytical change control activities for new products, in-line products, packaging, outsourcing, divestitures and compendial compliance. Partners with change control initiator/owner and various stakeholders in Regulatory, Technology, Supply Chain, Operations, and Quality to coordinate assessment and approval of analytical change controls. Ensures alignment across subject matter experts and stakeholders to implement analytical changes globally.



Operates in a complex business setting with significant regulatory complexity. Coordinates resolution of misaligned change control priorities across operating units within and across Small Molecule, Biologics, and Vaccines. Performs appropriate document review and change control quality approval activities associated with their position and ensures change control is in compliance with all regulatory and current Good Manufacturing Practices (cGMP) expectations.
- Ensures that all Analytical Standard documents are written clearly and unambiguous, are maintained in accordance with established divisional and departmental procedures, and issued in a timely fashion. Maintains active ingredient, intermediate, raw material, excipient, component and final product Analytical Standards.
- Performs appropriate document review and change control quality approval activities associated with their position and ensures change control is in compliance with all regulatory a

📌 Senior Specialist (Pune)
🏢 Msd
📍 Pune