We are seeking an experienced Production / Packing QMS Manager to lead Quality Management System (QMS) activities for a regulated Oral Solid Dosage (OSD) manufacturing facility. The role will be responsible for driving GMP compliance, managing quality systems, supporting regulatory inspections, and ensuring robust quality oversight across Production and Packing operations.

Key Responsibilities
Manage and drive QMS processes including Deviations, CAPA, Change Controls, Investigations, and Risk Assessments.
Ensure compliance with cGMP, Data Integrity (ALCOA+), and applicable regulatory requirements.
Review and monitor Production and Packing documentation including BMRs, BPRs, SOPs, and associated GMP records.
Lead root cause investigations and ensure effective implementation of CAPAs.
Facilitate Quality Risk Management (QRM)



activities and continuous improvement initiatives.
Support internal, customer, and regulatory audits and ensure timely closure of observations.
Track QMS metrics, identify trends, and drive compliance improvement programs.
Partner with cross-functional teams to maintain inspection readiness and strengthen quality culture.
Conduct GMP and QMS training programs for shop-floor personnel.

Qualifications
B.Pharm / M.Pharm / M.Sc. (Life Sciences, Chemistry or related discipline).
Robust understanding of pharmaceutical quality systems and GMP regulations.Preferred Experience
Experience with USFDA, MHRA, EU GMP, WHO GMP, PIC/S, or other regulated markets preferred.

📌 Looking For Production & Packing Qms For Osd Mfg Site Ahmedabad
🏢 Zydus Lifesciences
📍 Ahmedabad