We are looking for an experienced QC Analytical professional (6–12 years) with solid 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.

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