Analytical Research Associate

Jubilant Pharmova; Haridwar; On-site; INR 2,200,000 - 3,300,000; Full time

Job summary

Jubilant Pharmova in Haridwar seeks an experienced Analytical Method Validation specialist to independently plan, execute, review, and coordinate AMV, AMT, and related analytical activities for drug products and APIs, ensuring compliance with regulatory guidelines and site quality systems.

The role covers method verification, investigations, and data review, with hands-on expertise in HPLC/UPLC, LC-MS/MS, GC, dissolution testing, and related analytical instruments.

Qualifications

• M.Sc. in Chemistry/Analytical Chemistry/Pharmaceutical Chemistry required.
• M.Pharm in Pharmaceutical Analysis/Quality Assurance preferred.
• 8–12 years of pharma analytics/QC experience with AMV/AMT exposure.
• GMP documentation and regulatory reporting experience required.

Responsibilities

• Plan and execute analytical method validation/verification for assay, related substances/impurities, dissolution, content uniformity, and other tests.
• Prepare AMV protocols, validation reports, STPs, specifications, and supporting documentation.
• Coordinate Analytical Method Transfer (AMT) between development, QC, labs, and manufacturing.
• Review chromatographic data for GMP compliance and data integrity (ALCOA+).
• Assist investigations of OOS/OOT, system suitability failures, and instrument issues.
• Ensure timely closure of deviations, investigations, CAPAs, and change controls.

Skills

Analytical method validation

Quality compliance

Data integrity

GMP documentation

Education

M.Sc. in Chemistry/Analytical Chemistry/Pharmaceutical Chemistry

M.Pharm in Pharmaceutical Analysis/Quality Assurance

Tools

HPLC/UPLC

LC-MS/MS

GC/Headspace GC

Dissolution apparatus

UV-Vis spectrophotometer

Job description

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.