Quality control analyst

Enzene Biosciences Ltd · Pune district, India

We are looking for an experienced QC Analytical professional (6–12 years) with strong exposure to analytical testing, data review, and GMP-compliant quality systems in a biopharmaceutical environment.

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.