Job Summary

Position: Dy. Manager - QC

Location: Vapi

Experience: 6 - 8 Years

Industries: Pharma - API

Responsibilities

- Manage day-to-day Quality Control activities for raw materials, intermediates, APIs, finished products, and stability samples.
- Ensure compliance with cGMP, GLP, ICH, FDA, EU GMP, and regulatory requirements.
- Review and approve analytical test results, COAs, SOPs, STPs, specifications, and analytical reports.
- Supervise and guide QC analysts and senior executives to ensure timely sample analysis.
- Oversee operation, calibration, qualification, and maintenance of laboratory instruments (HPLC, GC, UV, FTIR, KF, TOC, Dissolution, etc.).
- Investigate OOS, OOT, laboratory deviations, incidents, and implement CAPA.
- Coordinate analytical method validation, verification, method transfer, and cleaning validation support.
- Ensure timely release of raw materials, intermediates, APIs, and stability samples.
- Review laboratory documentation, logbooks, chromatograms, and data integrity compliance (ALCOA+).
- Monitor laboratory inventory, chemicals, reagents, reference standards, and consumables.
- Support internal, customer, and regulatory audits and ensure timely closure of observations.




- Ensure compliance with data integrity policies and electronic systems.
- Prepare and review trend analysis, KPI reports, and QC performance metrics.
- Train and develop QC personnel on GMP, SOPs, safety, and analytical techniques.
- Coordinate with Production, QA, Warehouse, and Regulatory Affairs for quality-related activities.
- Ensure laboratory safety practices and adherence to EHS guidelines.
- Drive continuous improvement initiatives to enhance laboratory efficiency and compliance.

Required Skills
- cGMP, GLP, ICH Guidelines
- FDA / EU GMP Compliance
- HPLC, GC, UV, FTIR, KF, TOC
- Analytical Method Validation Transfer
- OOS / OOT / Deviation Investigation
- Stability Studies
- Data Integrity (ALCOA+)
- CAPA Management
- Laboratory Documentation
- Team Leadership People Management
- Audit Handling
- SAP/LIMS/Empower (preferred)
- Root Cause Analysis
- Risk Assessment
- Excellent Communication Problem-Solving Skills

Required Qualification B.Pharm/M.Pharm/B.Sc/M.Sc-Chemistry

Key Skills

- Day-to-day Quality Control
- HPLC
- Validation

📌 Dy. Manager - QC (Vapi)
🏢 Quality HR Services
📍 Vapi