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 professional 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 OOS, OOT, Deviations, CAPA, and Change Controls?
- Are you familiar with cGMP, GLP, GDP, and Data Integrity (ALCOA+) requirements?
- Have you supported USFDA, WHO-GMP, or customer 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
