Job Title: QA – QMS (Senior Executive)

Industry: API Pharmaceutical Manufacturing

Location: Turbhe, Navi Mumbai

Experience: 5–8 Years

Qualification: M.Sc. (Chemistry) / M.Pharm / B.Pharm

Job Description

We are looking for an experienced QA – QMS professional to manage and maintain the Quality Management System (QMS) in an API Pharmaceutical Manufacturing setting. The candidate will be responsible for ensuring compliance with cGMP and regulatory requirements while handling quality system activities and supporting audits.

Key Responsibilities
- Manage Quality Management System (QMS) activities including Deviations, CAPA, Change Controls, OOS, OOT, and Market Complaints.
- Prepare, review, and approve SOPs, specifications, protocols, reports, and quality documents.
- Review and maintain Product Quality Review (PQR/APQR) documentation.
- Conduct Root Cause Analysis (RCA) and Quality Risk Management (QRM) activities.
- Ensure compliance with cGMP, GDP, Data Integrity (ALCOA+), ICH Guidelines, WHO-GMP, USFDA, and Schedule M requirements.
- Coordinate and support internal audits,



customer audits, and regulatory inspections.
- Review validation documents related to process validation, cleaning validation, and equipment qualification.
- Conduct GMP, GDP, and QMS training programs across departments.
- Coordinate with QA, QC, Production, Engineering, and Regulatory Affairs to ensure timely closure of QMS records.
- Drive continuous improvement initiatives to strengthen the Quality Management System.

Pay: ₹500,000.00 - ₹650,000.00 per year

Benefits:
- Health insurance
- Provident Fund

Application Question(s):
- Total years of experience in Quality Assurance (QA)?
- How many years of experience do you have in the API Pharmaceutical industry?
- Do you have experience handling QMS activities such as Deviations, CAPA, Change Controls, OOS, and OOT?
- Have you prepared or reviewed PQR/APQR and SOPs?
- Are you familiar with cGMP, WHO-GMP, USFDA, ICH Guidelines, and Dat

📌 QA – QMS (Navi Mumbai)
🏢 Great Pacific Export
📍 Navi Mumbai