Walk-in || Quality Control Analyst

Role & responsibilities

• Perform chemical and instrumental analysis of raw materials, in-process samples, finished products, and stability samples.
• Conduct testing of injectable products as per approved specifications, STPs, and pharmacopoeial requirements.
• Handle instruments such as HPLC, GC, UV-Visible Spectrophotometer, FTIR, pH Meter, Karl Fischer, Dissolution Apparatus, and analytical balances as applicable.
• Perform assay, related substances/impurities, identification, pH, water content, particulate matter, clarity, and other applicable tests for injectable products.
• Ensure proper sampling, testing, documentation, and timely release of analytical results.
• Prepare and maintain analytical worksheets, raw data, test reports, logbooks, and other QC records.
• Follow GLP, GMP, data integrity (ALCOA+) and laboratory safety requirements.
• Investigate and report Out of Specification (OOS), Out of Trend (OOT), and laboratory incidents/deviations as per procedures.
• Support method validation, method verification, method transfer, analytical method development, and instrument qualification activities.
• Perform calibration, verification, and routine maintenance of QC laboratory instruments as per SOPs.
• Maintain proper laboratory housekeeping and ensure availability of chemicals, reagents, standards, and consumables.
• Support stability study testing and maintain stability-related documentation.
• Coordinate with QA, Production, Microbiology, and other cross-functional departments for timely completion of testing and investigations.
• Participate in internal audits, regulatory inspections, and customer audits as required.
• Ensure compliance with current IP, BP, USP, Ph. Eur. and other applicable pharmacopoeial requirements.
• Follow all applicable company SOPs, safety procedures, and EHS requirements.

Preferred candidate profile

• Hands-on experience in pharmaceutical QC laboratory operations, preferably injectable manufacturing.
• Practical knowledge of HPLC and other analytical instruments.
• Knowledge of GMP, GLP, OOS/OOT, deviation, CAPA, change control, and data integrity.
• Good understanding of pharmacopoeial testing and analytical procedures.
• Good documentation and communication skills.
• Ability to work independently as well as in a team.
• Willingness to work in shift operations, if required.