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
- Valuable 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

📌 QC Analytical Method Validation (AMV) Specialist (Baddi)
🏢 Maya Biotech
📍 Baddi