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 environment. 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 Data Integrity (ALCOA+)?
- Have you handled internal, customer, or regulatory audits?
- What is your current CTC? (₹ LPA)
- What is your expected CTC? (₹ LPA)
- What is your notice period?
- What is your current location?
- Are you willing to work in Turbhe, Navi Mumbai?
Work Location: In person
