Job DescriptionWe are looking for an experienced QC Analytical skilled (3 - 9 years) with strong exposure to analytical testing, data review, and GMP-compliant quality systems in a biopharmaceutical environment.
NKey Responsibilities:
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- In-process and product analysis of drug substances, drug products, stability samples, and protocol-based studies. N
- Instrument calibration and maintenance for HPLC, UFLC, Maurice systems, plate readers, and basic QC instruments (pH meter, osmometer, etc.). N
- Reference standard management including qualification and reconciliation activities. N
- Preparation and review of QC documentation such as Specifications, STPs, SOPs, CoAs, MTPs, MVPs, MVRs, and MTRs. N
- Conducting analyst qualification and training as part of routine training management. N
- Initiation, investigation, and closure of change controls and CAPA within due timelines. N
- Handling deviations, incidents, OOS,



and OOT investigations in compliance with procedures. N
- Technical proficiency in CEX-HPLC, SE-HPLC, RP-HPLC, ELISA, RT-PCR, and Capillary Electrophoresis. N
- Adherence to GMP, GLP, GDP, and Data Integrity practices in all QC operations. N
- Collaboration with cross-functional teams, ensuring effective communication and teamwork. N

nTechnical 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
NQualification:
NM.Sc., M.Pharm, M.Tech (Biotech), or relevant Master's degree.
NExperience:
N3 - 9 years of hands-on experience in QC Analytical functions within the biopharmaceutical industry.

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