QC Analytical Method Validation (AMV) Specialist

Designation

QC Analytical Method Validation (AMV) Specialist

Department

Quality Control (Analytical)

Location;- H.P BADDI

Purpose of the Role

To develop, validate, verify, transfer, and maintain analytical test methods in compliance with ICH, WHO-GMP, USFDA, EU-GMP, and applicable pharmacopoeial requirements, ensuring reliable, accurate, and reproducible analytical results.

Key Responsibilities

1. Analytical Method Validation (AMV)

• Prepare, review, and execute Analytical Method Validation (AMV) protocols and reports.
• Perform validation studies as per ICH Q2(R2) guidelines.
• Validate assay, related substances, dissolution, content uniformity, preservative content, residual solvents, and other analytical methods.
• Evaluate validation data and ensure compliance with predefined acceptance criteria.

2. Method Verification & Method Transfer

• Perform analytical method verification for pharmacopoeial methods.
• Coordinate analytical method transfer activities from R&D to QC and between manufacturing sites.
• Prepare method transfer protocols and reports.
• Investigate and resolve method transfer issues.

3. Analytical Testing

• Perform testing using HPLC, UPLC, GC, UV-Visible Spectrophotometer, FTIR, Dissolution Apparatus, Karl Fischer, pH Meter, TOC Analyzer, and other analytical instruments.
• Ensure compliance with approved specifications, test methods, and SOPs.

4. Documentation

• Prepare and review validation protocols, reports, SOPs, STPs, specifications, worksheets, and logbooks.
• Ensure compliance with Good Documentation Practices (GDP).
• Maintain complete validation records and raw data.

7. Investigation & Compliance

• Participate in OOS, OOT, atypical results, deviations, and laboratory investigations.
• Perform root cause analysis and recommend CAPA.
• Support Change Control and Risk Assessment activities related to analytical methods.

8. Regulatory Compliance

• Ensure compliance with:
• ICH Q2(R2) Analytical Validation Guidelines
• WHO-GMP
• Pharmacopoeial requirements (IP, BP, USP)
• Data Integrity (ALCOA+)
• Support regulatory inspections and customer audits.

Educational Qualification

• M.Sc. (Analytical Chemistry / Chemistry)
• B.Pharm / M.Pharm
• Equivalent qualification in Pharmaceutical Sciences

Experience

• 5-6 years of experience in Analytical QC with hands-on experience in Analytical Method Validation.
• Experience in injectable, ophthalmic, oral solid dosage, or other regulated pharmaceutical manufacturing preferred.

Technical Knowledge

• Analytical Method Validation (AMV)
• Analytical Method Transfer (AMT)
• Method Verification
• HPLC, UPLC, GC, UV, FTIR, Dissolution, KF
• ICH Q2(R2)
• OOS, OOT, CAPA, Change Control
• Good Documentation Practices (GDP)
• Data Integrity (ALCOA+)
• WHO-GMP, USFDA, EU-GMP

Key Skills

• Method Development & Validation
• Analytical Instrument Operation
• Technical Documentation
• Data Analysis & Interpretation
• Root Cause Analysis
• Problem Solving
• Attention to Detail
• Communication & Teamwork
• Time Management