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

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.

📌 Quality Control Analyst Solapur
🏢 Enzene Biosciences
📍 Solapur