Dy. Manager - QC

JobItUs; Vapi; On-site; INR 480,000 - 800,000; Full time

Job summary

JobItUs in Vapi seeks a Dy. Manager - QC with 6–8 years of QC/QA experience in pharma API or similar. You will lead daily QC activities, ensure adherence to cGMP/GLP/ICH and regulatory standards, and supervise analysts to deliver timely results.

The role involves instrument oversight (HPLC, GC, UV, FTIR, KF, TOC, dissolution), CAPA management, data integrity, and collaboration with QA, Production and Regulatory teams. Salary up to 8 LPA.

Qualifications

• Bachelor or Master degree in Pharmacy or Chemistry or equivalent.
• 6–8 years of experience in QC/QA within pharma APIs or finished products.

Responsibilities

• Manage day-to-day QC activities for materials, intermediates, APIs and finished products.
• Ensure compliance with cGMP, GLP, ICH, FDA and EU GMP standards.
• Review analytical results, COAs, SOPs and reports for accuracy and compliance.
• Supervise QC analysts and guide teams to timely sample analysis.
• Oversee calibration, qualification and maintenance of laboratory instruments.
• Investigate OOS/OOT deviations and implement CAPA actions.
• Coordinate validation, verification and method transfer activities.
• Ensure timely release of materials and stability samples.

Skills

cGMP/GLP/ICH

FDA/EU GMP

Analytical Instruments

Method Validation/Transfer

OOS/OOT Investigation

Stability Studies

Data Integrity (ALCOA+)

CAPA Management

Laboratory Documentation

Team Leadership

Audit Handling

SAP

LIMS

Empower

Root Cause Analysis

Risk Assessment

Communication & Problem-Solving

Education

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

Tools

SAP

LIMS

Empower

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 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

Salary :- Upto 8.00 LPA