Job Purpose To independently plan, execute, review, and coordinate analytical method validation, verification, transfer, and related analytical activities for drug products and APIs, ensuring compliance with applicable regulatory guidelines, pharmacopoeial requirements, approved procedures, and site quality systems.

Key Responsibilities
1. Analytical Method Validation
- Plan and execute analytical method validation/verification for Assay, Related Substances/Impurities, Dissolution, Content Uniformity, Residual Solvents, and other product-specific tests.
- Prepare and review AMV protocols, validation reports, STPs, specifications, worksheets, and supporting analytical documentation.
- Evaluate parameters such as specificity, accuracy, precision, linearity, range, robustness, solution stability, filter compatibility, LOD and LOQ, as applicable. 2. Method Transfer & Verification
- Coordinate Analytical Method Transfer (AMT) between development, QC, contract laboratories, and manufacturing sites.
- Perform pharmacopoeial method verification and method equivalency/comparative studies, where applicable. 3. Investigation & Troubleshooting
- Support investigation of OOS, OOT, laboratory incidents, atypical chromatographic behavior, system suitability failures, baseline disturbances,



peak integration issues, and instrument-related problems. 4. Documentation & Data Review
- Review chromatographic and analytical data for scientific and GMP compliance.
- Ensure data integrity and ALCOA+ principles are followed.
- Review calculations, system suitability, specifications, COAs, STPs, protocols, reports, and laboratory records.
- Ensure timely closure of deviations, investigations, CAPAs, and change controls related to assigned projects. 5. Instrumentation & Technical Expertise Hands-on knowledge/troubleshooting experience with analytical techniques such as:
- HPLC / UPLC
- UV-Visible Spectrophotometry
- Dissolution apparatus
- GC / Headspace GC
- LC-MS/MS
- GC-MS/MS
- Particle Size Analyzer and other product-specific analytical instruments 6. Qualification & Experience

Education:
M.
Sc. in Chemistry/Analytical Chemistry/Pharmaceutical Chemistry or M.
Pharm in Pharmaceutical Analysis/Quality Assurance.

Experience:
Typically 8-12 years of relevant pharmaceutical analytical/QC experience, with substantial hands-on exposure to analytical method validation, method transfer, investigations, and regulatory documentation.

📌 Analytical Research Associate (Roorkee)
🏢 Jubilant Pharmova
📍 Roorkee