Quality Control Analyst

We are looking for an experienced QC Analytical professional (3 - 9 years) with strong exposure to analytical testing, data review, and GMP-compliant quality systems in a biopharmaceutical environment. Key Responsibilities: - In-process and product analysis of drug substances, drug products, stability samples, and protocol-based studies. - Instrument calibration and maintenance for HPLC, UFLC, Maurice systems, plate readers, and basic QC instruments (pH meter, osmometer, etc.). - Reference standard management including qualification and reconciliation activities. - Preparation and review of QC documentation such as Specifications, STPs, SOPs, CoAs, MTPs, MVPs, MVRs, and MTRs. - Conducting analyst qualification and training as part of routine training management. - Initiation, investigation, and closure of change controls and CAPA within due timelines. - Handling deviations, incidents, OOS, and OOT investigations in compliance with procedures. - Technical proficiency in CEX-HPLC, SE-HPLC, RP-HPLC, ELISA, RT-PCR, and Capillary Electrophoresis. - Adherence to GMP, GLP, GDP, and Data Integrity practices in all QC operations. - Collaboration with cross-functional teams, ensuring effective communication and teamwork. Technical Expertise Required: • CEX-HPLC, SE-HPLC, RP-HPLC • ELISA, RT-PCR • Capillary Electrophoresis (Maurice System) • Analytical data review and laboratory documentation Qualification: M.Sc., M.Pharm, M.Tech (Biotech), or relevant Master's degree. Experience: 3 - 9 years of hands-on experience in QC Analytical functions within the biopharmaceutical industry.