Job Description

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

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Key Responsibilities:

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

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

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Reference standard management including qualification and reconciliation activities.

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

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

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Initiation, investigation, and closure of change controls and CAPA within due timelines.

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Handling deviations, incidents, OOS,



and OOT investigations in compliance with procedures.

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

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

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Collaboration with cross-functional teams, ensuring effective communication and teamwork.

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Technical Expertise Required:

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CEX-HPLC, SE-HPLC, RP-HPLC

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ELISA, RT-PCR

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Capillary Electrophoresis (Maurice System)

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Analytical data review and laboratory documentation

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Qualification:

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

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Experience:

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

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