QC Analytical Method Validation (AMV) Specialist

Maya Biotech; Solan; On-site; INR 900,000 - 1,300,000; Full time

Job summary

Maya Biotech in Himachal Pradesh seeks an experienced QC AMV Specialist to develop and validate analytical methods per ICH/WHO-US GMP standards. You will verify and transfer methods, perform testing with HPLC/UPLC/GC/UV-Vis, and ensure GDP-compliant documentation.

Experience in AMV, AMT, and regulatory compliance is essential; familiarity with injectable and dosage form testing is preferred. On-site role in Solan area with collaboration across QC teams.

Qualifications

• M.Sc. in Analytical Chemistry or Chemistry or equivalent.
• B.Pharm or M.Pharm degree with pharmaceutical focus.
• Hands-on AMV experience in QC and regulated pharma.

Responsibilities

• Validate AMV protocols and reports per ICH Q2(R2).
• Transfer methods between R&D, QC and sites; issue protocols.
• Perform analytical testing using HPLC/UPLC, GC, UV-Vis, FTIR.
• Maintain GDP-compliant documentation and raw data.

Skills

AMV

AMT

Method Transfer

Analytical Instrumentation

Education

M.Sc. (Analytical Chemistry) / Chemistry

B.Pharm / M.Pharm

Equivalent in Pharmaceutical Sciences

Tools

HPLC

UPLC

GC

UV-Vis

Job description

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