Job Title: Senior QC Reviewer
Department: Quality Control (QC)
Location: Turbhe Navi Mumbai Manufacturing Plant
Job Summary
The Senior QC Reviewer is responsible for reviewing and approving analytical data, laboratory records, and quality control documentation to ensure compliance with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), data integrity principles (ALCOA+), and applicable regulatory requirements. The role provides technical guidance to QC analysts, supports investigations, and ensures timely review of laboratory documentation for batch release.
Key Responsibilities
- Review analytical data, raw data, worksheets, chromatograms, spectra, and laboratory notebooks for accuracy, completeness, and compliance.
- Review and approve Certificates of Analysis (COA), analytical reports, and laboratory documentation.
- Verify analytical calculations, data transcription, specifications, and test methods.
- Ensure compliance with GMP, GLP, GDP, ALCOA+, and data integrity requirements.
- Review instrument logbooks, calibration, qualification, and maintenance records.
- Identify and resolve documentation errors, discrepancies, and review comments before batch disposition.
- Review and support investigations related to OOS (Out of Specification), OOT (Out of Trend), deviations, laboratory incidents, CAPA, and change controls.
- Provide technical guidance and mentoring to QC Analysts and QC Reviewers.
- Coordinate with QA, Production, Warehouse, and Regulatory Affairs to ensure timely completion of documentation.
- Ensure review activities are completed within established timelines to support batch release.
- Participate in method validation, method transfer, stability studies, and analytical troubleshooting, where applicable.
- Support internal audits, customer audits, and regulatory inspections by providing required laboratory documentation.
- Ensure compliance with SOPs, pharmacopoeial requirements (IP/USP/BP/EP), and ICH guidelines.
- Recommend and implement continuous improvements in laboratory documentation and review processes.
- Maintain confidentiality, accuracy, and integrity of laboratory records.
Qualification
- M.Sc. (Chemistry) or B.Sc. (Chemistry)
- B.Pharm / M.Pharm (Preferred)
Experience
- 7–10 years of experience in Quality Control within the API, pharmaceutical, or formulation industry.
- Minimum 5 years of experience in analytical data/document review is preferred.
- Experience handling regulatory inspections (USFDA, EU GMP, MHRA, WHO GMP, etc.) is an advantage.
Required Skills
- Strong knowledge of GMP, GLP, GDP, Data Integrity (ALCOA+), and ICH guidelines.
- Sound knowledge of analytical instruments such as HPLC, GC, UV-Visible Spectrophotometer, FTIR, Dissolution, Karl Fischer, and related laboratory equipment.
- Excellent documentation review and analytical skills.
- Knowledge of pharmacopoeias (IP, USP, BP, EP).
- Good understanding of laboratory investigations (OOS, OOT, deviations, CAPA).
- Proficiency in Microsoft Office and Laboratory Information Management Systems (LIMS), if applicable.
- Strong communication, leadership, and mentoring skills.
Key Performance Indicators (KPIs)
- Timely completion of QC document reviews.
- Zero critical documentation review errors.
- Compliance with GMP, GLP, and data integrity requirements.
- Timely support for batch release.
- Timely closure of review observations and investigations.
- Successful regulatory and customer audit outcomes.
- Reduction in documentation errors through effective review.
Key Competencies
- Leadership and mentoring
- Attention to detail
- Analytical thinking
- Decision-making
- Quality and compliance focus
- Time management
- Communication and teamwork
Working Conditions
- QC laboratory environment.
- Standard working hours with flexibility during audits, validations, and production requirements.
- Compliance with laboratory safety procedures and mandatory use of PPE.
This JD is suitable for a Senior QC Reviewer in an API or pharmaceutical manufacturing facility, responsible for ensuring the accuracy, integrity, and regulatory compliance of all Quality Control laboratory documentation and analytical data.
Pay: ₹600,000.00 - ₹750,000.00 per year
Benefits:
- Health insurance
- Provident Fund
Work Location: In person
