22 Aug
|
Enzene Biosciences
|
Pune
22 Aug
Enzene Biosciences
Pune
We are looking for an experienced QC Analytical qualified (6–12 years) with solid exposure to analytical testing, data review, and GMP-compliant quality systems in a biopharmaceutical workplace.
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
🏢 Enzene Biosciences
📍 Pune