To conduct and document analytical method validation (AMV), method verification, and method transfer activities for raw materials, in-process samples, and finished pharmaceutical products in compliance with ICH Q2(R1), GMP, and regulatory standards.

 

Key Responsibilities

 

1. Analytical Method Validation

  • Perform validation of analytical methods as per ICH Q2(R1) guidelines for:
  • Assay and related substances (HPLC, UV)
  • Dissolution, content uniformity, residual solvents (GC)
  • Identification and other physicochemical parameters
  • Conduct validation parameters: specificity, accuracy, precision, linearity, robustness, LOD/LOQ, system suitability, etc.
  • Document results in validation protocols and summary reports.

 

2. Method Verification

  • Verify compendial methods (IP/BP/USP/Ph.Eur.) for RM/FP/IP samples.
  • Confirm suitability of method for intended use before routine application.
  • Prepare method verification reports and submit for review/approval.

 

3. Method Transfer

  • Participate in analytical method transfer (AMT) from R&D or third-party units.
  • Execute comparative testing for transferred methods and compile transfer protocols.
  • Coordinate with sending/receiving sites for method harmonization and troubleshooting.

 

4. Instrument Handling

  • Operate and troubleshoot instruments such as:
  • HPLC (Empower, LabSolutions, Chromeleon)
  • GC (Headspace, FID)
  • UV-Visible Spectrophotometer
  • FTIR, Dissolution Apparatus, TOC (if applicable)

 

5. Documentation & Compliance

  • Prepare and review:
  • Validation protocols and reports
  • Analytical worksheets and system suitability documents
  • Adhere to GMP, GLP, and ALCOA+ principles.
  • Maintain instrument logs, change controls, and CAPA logs where applicable.

 

6. Audit Readiness & Regulatory Support

  • Ensure all AMV data is audit-ready and compliant with regulatory expectations.
  • Support in regulatory inspections (USFDA, MHRA, WHO-GMP, etc.).
  • Address audit observations related to analytical validation.

 

Instruments & Software Used

  • HPLC, GC (Headspace, FID)
  • UV-Vis Spectrophotometer, FTIR
  • Dissolution Testers
  • CDS Software: Empower / LabSolutions / Chromeleon

 

Education :M.Sc. (Analytical / Organic Chemistry) / M.Pharm

 

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