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

- 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.

/n /n /n Technical Expertise Required: /n • CEX-HPLC, SE-HPLC, RP-HPLC /n • ELISA, RT-PCR /n • Capillary Electrophoresis (Maurice System) /n • Analytical data review and laboratory documentation /n /n Qualification: /n M.Sc., M.Pharm, M.Tech (Biotech), or relevant Master's degree. /n /n Experience: /n 3 - 9 years of hands-on experience in QC Analytical functions within the biopharmaceutical industry.

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