- Job title: Manager – Analytical Quality Assurance
- Company: Enzene Biosciences Ltd.
- Location: Chakan, Pune, Maharashtra, India

Description

About Enzene

Enzene Biosciences, is a biologics CDMO with an EU-GMP certified biosimilars platform and operations in India and the US.

About the role

We’re looking for an Analytical QA Lead to oversee quality in our QC lab, covering document approval, QMS, batch release and audits. The role needs 15+ years of experience.

Key responsibilities

Document review and approval

- Review and approve master and executed quality documents: TDS, specifications, STPs, SAR, SSR, study protocols and reports
- Approve GMP documents for QC: qualification, validation, periodic verification, calibration and breakdown reports
- Approve MTP, MTR, MVP, MVR and study protocols/reports for fitness to intended use
- Review and approve IRS qualification protocols and reports

Release and COA
- Approve COA/ROA for raw materials, packaging materials and consumables
- Approve COA/ROA for drug substance and drug product
- Approve batch release documentation, checking data integrity,



completeness and regulatory compliance

QMS
- Make sure OOS, OOT, OOL, LIR, deviations, NCRs, change controls, risk and impact assessments and CAPA are reviewed and closed on time
- Escalate critical quality issues, investigation outcomes and non-conformances to management and clients

Audits and compliance
- Act as the Analytical QA SME in client, customer and regulatory audits
- Drive timely audit responses and track how compliance actions are implemented
- Oversee stability studies so they run on schedule and to protocol
- Carry out routine QA rounds in QC labs to check cGMP and GLP compliance, and close any gaps

People
- Train team members on quality systems and GMP

What we’re looking for

- 15+ years in Analytical QA / QC within pharma or biologics
- Robust knowledge of QMS, data integrity (ALCOA+), and cGMP/GLP in QC labs
- Experience facing USFDA, EMA or MHRA audits
- Biosimilars, mAbs or CDMO experience is a strong plus
- M.Sc / M.Pharm or equivalent

📌 Manager Analytical Quality (Chakan)
🏢 Enzene Biosciences
📍 Chakan