Job Title: Executive – Quality Control (MVL Analytical)
Location: Pune, Maharashtra, India
Department: Quality Control
Employment Type: Permanent (ENZBIO) | Full-Time
Job Category: Analytical Development | Method Validation | Biopharmaceutical Quality Control
Experience Required: 2–5 years of hands-on experience in analytical methods including HPLC, ELISA, RT-PCR, and other biopharma assays
Role Overview
The Executive – Quality Control (MVL Analytical) will be responsible for method validation, stability studies, biosimilarity assessments, and laboratory documentation management in compliance with CGMP standards. The role involves coordination with internal teams and external vendors, laboratory maintenance, and support for continuous quality improvement initiatives.
This position requires expertise in advanced analytical techniques, instrument handling, and regulatory documentation for biopharmaceutical products.
Key Responsibilities
Perform method validation and verification for drug substance (DS), drug product (DP), and in-process samples
Conduct stability studies, IRS qualification, and biosimilarity assessments
Prepare and review analytical documentation including Specifications, Standard Test Procedures (STPs), Technical Data Sheets (TDS), SOPs, Certificates of Analysis (COA), Method Validation Protocols (MVP), Reports (MVR), and Method Transfer Reports (MTR)
Coordinate with vendors for external instrument calibration and MVL personnel for in-house calibration and verification
Manage labware, chemicals, standards, kits, and consumables; ensure stock control and timely requisitioning
Maintain laboratory equipment, instruments, and usage logbooks
Conduct analyst qualification and provide training to MVL staff
Initiate, investigate, and track Quality Management System (QMS) activities
Ensure full compliance of MVL laboratory operations with CGMP and safety standards
Perform any additional tasks assigned by the reporting manager
Required Experience
2–5 years of relevant hands-on experience in biopharmaceutical analytical laboratories
Proficiency in techniques such as:
CEX-HPLC, SE-HPLC
ELISA
HC-DNA by RT-PCR
Maurice, SOLO VPE
HCP analysis, Peptide Mapping, Glycan Analysis
Capillary Electrophoresis
Strong understanding of CGMP compliance and quality documentation
Educational Qualifications
M.Sc., M. Pharm., or Master’s degree in Biotechnology or relevant Life Sciences discipline
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