Job Description We are looking for an experienced QC Analytical professional (3 - 9 years) with solid exposure to analytical testing, data review, and GMP-compliant quality systems in a biopharmaceutical environment. n Key Responsibilities: n n In-process and product analysis of drug substances, drug products, stability samples, and protocol-based studies.n Instrument calibration and maintenance for HPLC, UFLC, Maurice systems, plate readers, and basic QC instruments (pH meter, osmometer, etc.). n Reference standard management including qualification and reconciliation activities. n Preparation and review of QC documentation such as Specifications, STPs, SOPs, CoAs, MTPs, MVPs, MVRs, and MTRs.n Conducting analyst qualification and training as part of routine training management. n Initiation, investigation, and closure of change controls and CAPA within due timelines. n Handling deviations, incidents, OOS,



and OOT investigations in compliance with procedures. n Technical proficiency in CEX-HPLC, SE-HPLC, RP-HPLC, ELISA, RT-PCR, and Capillary Electrophoresis.n Adherence to GMP, GLP, GDP, and Data Integrity practices in all QC operations. n Collaboration with cross-functional teams, ensuring effective communication and teamwork. n n Technical Expertise Required: n• CEX-HPLC, SE-HPLC, RP-HPLC n • ELISA, RT-PCR n • Capillary Electrophoresis (Maurice System)n• Analytical data review and laboratory documentation n Qualification: n M.Sc., M.Pharm, M.Tech (Biotech), or relevant Master's degree. n Experience: n 3 - 9 years of hands-on experience in QC Analytical functions within the biopharmaceutical industry.

📌 Quality Control Analyst, Pune (India)
🏢 Important Business
📍 India