Job DescriptionWe are looking for an experienced QC Analytical qualified (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:
n• CEX-HPLC, SE-HPLC, RP-HPLC
n• ELISA, RT-PCR
n• Capillary Electrophoresis (Maurice System)
n• 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 (Pune)
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