We are looking for an experienced QC Analytical qualified (3 - 9 years) with strong exposure to analytical testing, data review, and GMP-compliant quality systems in a biopharmaceutical environment.

In-process and product analysis of drug substances, drug products, stability samples, and protocol-based studies.

Instrument calibration and maintenance for HPLC, UFLC, Maurice systems, plate readers, and basic QC instruments (pH meter, osmometer, etc.).

Reference standard management including qualification and reconciliation activities.

Preparation and review of QC documentation such as Specifications, STPs, SOPs, CoAs, MTPs, MVPs, MVRs, and MTRs.

Conducting analyst qualification and training as part of routine training management.

Technical proficiency in CEX-HPLC, SE-HPLC, RP-HPLC, ELISA, RT-PCR, and Capillary Electrophoresis.

Adherence to GMP, GLP, GDP, and Data Integrity practices in all QC operations.

CEX-HPLC, SE-HPLC, RP-HPLC

• ELISA, RT-PCR

• Analytical data review and laboratory documentation

M.Pharm, M.Tech (Biotech), or relevant Master's degree.

Experience:

3 - 9 years of hands-on experience in QC Analytical functions within the biopharmaceutical industry.

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