Job Description:

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 Documentati

📌 Dy Manager Vapi
🏢 Quality HR India
📍 Vapi