Quality Control Analyst

Enzene Biosciences Ltd; Pune District; On-site; INR 600,000 - 1,200,000; Full time

Job summary

Enzene Biosciences Ltd. is seeking an experienced QC Analytical professional (3-9 years) with strong exposure to analytical testing, data review and GMP-compliant quality systems in a biopharmaceutical setting.

Responsibilities include in-process/product analysis, instrument calibration for HPLC/UFLCP Maurice systems, and management of reference standards, specifications, SOPs and CoAs. The role requires hands-on QC work and collaboration with cross-functional teams.

Qualifications

• 3–9 years hands-on QC Analytical in biopharma.
• Master’s degree in Biotech/Pharma or related field.
• Experience with GMP, GLP, GDP and data integrity.

Responsibilities

• In-process and product analysis of drug substances/products and stability samples.
• Calibration and maintenance of HPLC, UFLC, Maurice systems, plate readers, pH meters and related QC instruments.
• Reference standard management including qualification and reconciliation.
• Prepare/review QC documents: Specifications, STPs, SOPs, CoAs, MTPs, MVPs, MVRs, MTRs.
• Analyst qualification and routine training management.
• Initiate/ investigate/ close change controls and CAPA within timelines.
• Handle deviations, incidents, OOS, OOT per procedures.
• Apply CEX-HPLC, SE-HPLC, RP-HPLC, ELISA, RT-PCR, Capillary Electrophoresis.
• Adhere to GMP, GLP, GDP and Data Integrity in QC operations.
• Collaborate with cross-functional teams and communicate effectively.

Skills

Analytical data review

GMP compliance

QC documentation

Team collaboration

Education

M.Sc. in Biotech/Science

M.Pharm

M.Tech (Biotech)

Tools

HPLC

UFLC

Maurice system

Plate readers

pH meter

Osmometer

Capillary Electrophoresis

ELISA

RT-PCR

Job description

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

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

• 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.