Quality Control Analyst

Enzene Biosciences Ltd · Pune district, India

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

Key Responsibilities:

• 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.
• Initiation, investigation, and closure of change controls and CAPA within due timelines.
• Handling deviations, incidents, OOS, and OOT investigations in compliance with procedures.
• 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.
• Collaboration with cross-functional teams, ensuring effective communication and teamwork.

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:

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