Job Title: QC Reviewer / QMS

Industry: API Pharmaceutical Manufacturing

Location: Turbhe, Navi Mumbai

Experience: 5–8 Years

Qualification: M.Sc. (Chemistry)

Job Description

We are looking for an experienced QC Reviewer / QMS skilled to join our Quality Control team in an API Pharmaceutical Manufacturing company. The candidate will be responsible for reviewing analytical data, managing Quality Management System (QMS) activities, ensuring data integrity, and maintaining compliance with cGMP and regulatory requirements.

Key Responsibilities
- Review analytical raw data, chromatograms, calculations, and laboratory documentation.
- Review Certificates of Analysis (COA), analytical reports, and test results.
- Handle QMS activities including Deviations, OOS, OOT, CAPA, Change Controls, and Laboratory Incidents.
- Ensure compliance with cGMP, GLP, GDP, Data Integrity (ALCOA+), and regulatory guidelines.
- Review and maintain SOPs, STPs, specifications, analytical methods, and laboratory records.
- Support internal audits, customer audits, and regulatory inspections.
- Coordinate with QA,



Production, ADL, and Regulatory Affairs for investigations and document review.
- Ensure timely closure of QMS records and maintain audit readiness.
- Drive continuous improvement initiatives related to laboratory quality systems.

Required Skills
- QC Data Review
- Quality Management System (QMS)
- OOS / OOT Investigation
- Deviations & CAPA
- Change Control
- COA Review
- HPLC / GC Documentation Review
- Data Integrity (ALCOA+)
- cGMP / GLP / GDP
- ICH Guidelines
- Microsoft Office
- LIMS / ERP (Preferred)

Pay: ₹700,000.00 - ₹800,000.00 per year

Benefits:
- Health insurance
- Provident Fund

Application Question(s):
- Total years of experience in Quality Control?
- How many years of experience do you have in the API Pharmaceutical industry?
- Do you have experience in reviewing HPLC, GC, and other analytical raw data?
- Do you have experience handling QMS activities such as

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