Research Analyst

Job Description Research Analyst
Department: ADL (Analytical Development Laboratory)
Designation: Research Analyst
Location: Hadpsar, Pune
Experience: 2-5 Years
Qualification: M.Sc./B.Sc. in Chemistry / Analytical Chemistry or equivalent
Job Purpose
To perform analytical testing, method development/optimization, method validation, and routine analysis of raw materials, in-process samples, finished products, and other samples in accordance with approved procedures, quality standards, and applicable regulatory requirements.
Key Responsibilities

• Perform analytical testing of raw materials, intermediates, finished products, and stability samples as per approved methods and specifications.
• Execute HPLC, GC, UV-Visible Spectrophotometer, FTIR, dissolution, pH, moisture/LOD and other applicable analytical techniques.
• Support analytical method development, optimization, and method transfer activities.
• Perform analytical method validation/verification as per applicable guidelines and internal procedures.
• Prepare and maintain analytical solutions, reagents, mobile phases, standards, and reference materials.
• Operate analytical instruments and ensure proper instrument usage, calibration, and maintenance.
• Review analytical results and ensure accurate documentation of observations, calculations, chromatograms, and test results.
• Investigate OOS/OOT results and support laboratory investigations and CAPA activities.
• Maintain laboratory records, worksheets, logbooks, and analytical reports in accordance with GLP/GMP and SOP requirements.
• Coordinate with QA, QC, Production, R&D, and other relevant departments for analytical requirements.
• Support preparation and review of analytical protocols, reports, specifications, and SOPs.
• Ensure proper handling, labeling, storage, and disposal of samples and chemicals.
• Maintain laboratory housekeeping and comply with all applicable EHS and safety requirements.
• Participate in internal/external audits and provide required analytical documentation.
• Stay updated with current analytical techniques, regulatory requirements, and laboratory practices.

Required Technical Skills

• Good knowledge of analytical chemistry and pharmaceutical/chemical analysis.
• Hands-on experience with HPLC and other analytical instruments.
• Knowledge of chromatographic principles and analytical calculations.
• Understanding of method validation parameters such as accuracy, precision, specificity, linearity, range, robustness, LOD, and LOQ.
• Basic understanding of GMP, GLP, data integrity, and documentation practices.
• Ability to interpret chromatograms and analytical data.
• Good working knowledge of MS Excel and analytical documentation.