Welcome Back

Google icon Sign in with Google
OR
I agree to abide by Pharmadaily Terms of Service and its Privacy Policy

Create Account

Google icon Sign up with Google
OR
By signing up, you agree to our Terms of Service and Privacy Policy
Instagram
youtube
Facebook

Executive

Enzene Biosciences Ltd.
Enzene Biosciences Ltd.
2-5 years
Not Disclosed
Pune, India
10 Feb. 13, 2026
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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