QC Analytical Method Validation (AMV) Specialist

Location: Baddi, Himachal Pradesh
Department: Quality Control (Analytical)
Experience: 5–6 Years
Qualification: M.Sc. (Analytical Chemistry/Chemistry), B.Pharm, M.Pharm or equivalent qualification in Pharmaceutical Sciences
Industry: Pharmaceutical Manufacturing
Employment Type: Full-Time

Job Overview

ACME HR Consulting is looking for an experienced QC Analytical Method Validation (AMV) Specialist for a pharmaceutical manufacturing facility in Baddi, Himachal Pradesh.

The ideal candidate should have 5–6 years of experience in Analytical Quality Control (QC), with strong hands-on expertise in Analytical Method Validation (AMV), Analytical Method Transfer (AMT), method verification and analytical instrument operation.

The candidate will be responsible for developing, validating, verifying, transferring and maintaining analytical test methods in compliance with ICH, WHO-GMP, USFDA, EU-GMP and applicable pharmacopoeial requirements.

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 analytical method transfer issues.

3. Analytical Testing

• Perform analytical testing using the following instruments:
  • HPLC and UPLC
  • GC (Gas Chromatography)
  • UV-Visible Spectrophotometer
  • FTIR
  • Dissolution Apparatus
  • Karl Fischer (KF)
  • pH Meter
  • TOC Analyzer
• 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.

5. 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.

6. Regulatory Compliance

• Ensure compliance with ICH Q2(R2) Analytical Validation Guidelines.
• Follow WHO-GMP, USFDA and EU-GMP requirements.
• Ensure compliance with pharmacopoeial requirements (IP, BP and USP).
• Maintain Data Integrity as per ALCOA+ principles.
• Support regulatory inspections and customer audits.

Educational Qualification

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

Required Experience

• 5–6 years of experience in Analytical Quality Control (QC).
• Hands-on experience in Analytical Method Validation (AMV).
• Experience in injectable, ophthalmic, oral solid dosage or other regulated pharmaceutical manufacturing is preferred.

Technical Skills Required

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

Key Competencies

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

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