We are looking for an experienced QC Analytical qualified (6–12 years) with robust exposure to analytical testing, data review, and GMP-compliant quality systems in a biopharmaceutical setting.
Key Responsibilities:
• Review analytical data for DS, DP, stability, method validation, and method transfer samples.
• Perform and review chromatographic and plate-based analytical techniques.
• Manage reference standards, laboratory documentation, calibration activities, and inventory.
• Handle investigations related to Deviations, OOS, OOT, CAPA, and Change Controls.
• Support equipment qualification (IQ/OQ/PQ), analyst qualification, and training activities.
• Ensure compliance with GMP, GLP, and GDP requirements.
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:
6–12 years of hands-on experience in QC Analytical functions within the biopharmaceutical industry.

📌 Quality Control Analyst Pune (India)
🏢 Enzene Biosciences
📍 India