Job Description We are looking for an experienced QC Analytical skilled (3 - 9 years) with strong 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)
🏢 Enzene Biosciences
📍 Pune