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