Executive- Quality Control (AMV)

analytical method validation (AMV), method verification, and method transfer

ICH Q2(R1)

GMP

regulatory standards

Key Responsibilities

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