Looking For Production & Packing QMS For OSD Mfg site

Zydus Lifesciences; Ahmedabad District; On-site; INR 1,800,000 - 2,400,000; Full time

Job summary

Zydus Lifesciences Ahmedabad is seeking an experienced Production / Packing QMS Manager to lead quality management activities for a regulated OSD manufacturing facility.

The role focuses on driving GMP compliance, managing QMS, supporting regulatory inspections, and ensuring robust quality oversight across Production and Packing operations.

Qualifications

• B.Pharm / M.Pharm / M.Sc. in Life Sciences, Chemistry or related.
• Strong understanding of pharma quality systems and GMP.
• Experience with USFDA, MHRA, EU GMP, WHO GMP, PIC/S or similar markets preferred.

Responsibilities

• Manage QMS processes including Deviations, CAPA, Change Controls, Investigations and Risk Assessments.
• Ensure cGMP compliance and Data Integrity (ALCOA+).
• Review Production and Packing docs (BMRs/BPRs/SOPs) and GMP records.
• Lead root cause investigations and CAPA implementation.
• Support internal, customer and regulatory audits; close observations timely.
• Track QMS metrics, identify trends and drive improvement programs.
• Partner with cross-functional teams to ensure inspection readiness.

Skills

QMS management

CAPA

Deviations

Change Controls

Investigations

Risk Assessments

Data Integrity

GMP compliance

Audits

Education

B.Pharm / M.Pharm / M.Sc.

Job description

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).
• Strong 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.