QC Reviewer

Job Title

QC Reviewer – Analytical Quality Control

Location

Turbhe, Navi Mumbai

Company

Anazeal Analyticals & Research Pvt. Ltd.

Department

Quality Control / Quality Assurance

Job Summary

The QC Reviewer is responsible for independent review of analytical data, test reports, and documentation to ensure accuracy, completeness, and compliance with regulatory guidelines such as GMP, GLP, and international regulatory requirements. The role supports data integrity and timely delivery of high-quality analytical results to clients.

Key Responsibilities

• Review analytical raw data, chromatograms, calculations, and test results for accuracy and completeness
• Verify compliance with GMP/GLP, SOPs, and regulatory guidelines (ICH, FDA, EMA as applicable)
• Review Certificates of Analysis (COA), analytical reports, and method validation/verification documents
• Ensure data integrity principles (ALCOA+) are followed
• Identify deviations, discrepancies, and out-of-specification (OOS) results and support investigations
• Review laboratory notebooks, worksheets, and electronic data
• Ensure timely review and approval of analytical documents as per project timelines
• Support audits and inspections by regulatory authorities and clients
• Coordinate with analysts, QA, and project teams to resolve review comments
• Participate in continuous improvement and quality initiatives

Skills & Competencies

• Strong understanding of GMP, GLP, and data integrity requirements
• Excellent attention to detail and documentation skills
• Good understanding of regulatory expectations (US FDA, WHO, ICH)
• Ability to work independently and manage multiple priorities
• Good communication and coordination skills
• Proficiency in MS Office and laboratory documentation systems

Preferred Experience

• Experience in CRO/analytical testing laboratory
• Exposure to method validation, stability studies, and regulatory submissions
• Experience handling audits and inspections

Work Environment

• Analytical laboratory and office-based role
• Standard working hours with flexibility during audits or critical timelines

Job Types: Full-time, Permanent

Work Location: In person