QC Reviewer - Sikkim II

Name of the Company – Zydus Healthcare Limited Industry – Pharmaceuticals Website of the company - <https://www.zyduslife.com/zyduslife/> Location –Sikkim Unit II Position - Assistant / Deputy Manager Qualification – <M.Sc>. / B. Pharma / M. Pharma Experience Required – Between 06 - 10 Years of Experience Role – QC Reviewer Department: Quality Control Job Summary Responsible for reviewing analytical data, laboratory documentation, and quality records to ensure compliance with cGMP, data integrity requirements, approved specifications, and regulatory guidelines. The role supports timely release of raw materials, packaging materials, in-process samples, stability samples, and finished products. Key Responsibilities Review analytical data, chromatograms, laboratory notebooks, worksheets, and raw data generated during routine analysis and stability studies. Verify analytical results obtained from HPLC, GC, UV-Visible Spectrophotometer, Dissolution, FTIR, KF, and other analytical instruments. Ensure compliance of analytical documentation with approved specifications, SOPs, STPs, cGMP, GLP, and regulatory requirements. Review and approve Certificates of Analysis (COA), analytical reports, method validation reports, method transfer documents, and stability reports. Evaluate and support investigations related to OOS, OOT, deviations, laboratory incidents, and atypical results. Verify calculations, data transcription, integration events, audit trails, and compliance with Data Integrity (ALCOA+) principles. Coordinate with QC Analysts, QA, Production, Warehouse, and Regulatory departments for timely review and disposition of materials and products. Ensure laboratory records are complete, accurate, and audit-ready for regulatory inspections and customer audits. Participate in internal audits, risk assessments, CAPA implementation, and continuous improvement projects. Mentor and guide junior analysts and reviewers while promoting quality culture and compliance within the laboratory. Key Skills Analytical Data Review HPLC, GC, Dissolution, UV, FTIR Review OOS/OOT Investigation Handling Stability Data Review Data Integrity (ALCOA+) cGMP & GLP Compliance Method Validation & Method Transfer Audit & Inspection Readiness Documentation Review Team Coordination & Leadership