Dy. Manager - QC

Job Summary 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 Key Skills

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