Executive – QA (IPQA – Drug Substance) Job At Enzene
Enzene is hiring an Executive / Senior Executive – QA (IPQA – Drug Substance) in Pune. This Quality Assurance Job role focuses on ensuring cGMP compliance at the Drug Substance manufacturing shop floor through line clearance, in-process quality oversight, documentation review, and QMS activities. It is ideal for QA professionals with strong hands-on DS experience and regulatory exposure. Graduates seeking M Pharma jobs or Pharmacy jobs can apply now.
Job Details
- Job Title: Executive / Senior Executive – QA (IPQA – DS)
- Location: Pune, Maharashtra, India
About the Company
Enzene is a leading biopharmaceutical organization focused on delivering high-quality biologics and drug substances through innovation, compliance, and operational excellence. The company operates with strong cGMP standards and global regulatory alignment to support regulated markets worldwide.
Educational Requirements
-
M. Pharm in a relevant scientific discipline
Key Responsibilities
- Perform manufacturing line clearance on the shop floor for Drug Substance activities.
- Ensure execution and compliance of in-process checks during manufacturing operations.
- Conduct routine GMP rounds at the DS facility and document observations.
- Review online Batch Manufacturing Records (BMR) for accuracy, completeness, and compliance.
- Review and approve process validation and cleaning validation protocols and reports.
- Review, manage, and update SOPs and shop-floor related protocols and reports.
- Coordinate sample collection and submission as per BMR, specifications, validation, and stability protocols.
- Conduct shop floor compliance rounds and follow up on corrective and preventive actions.
- Prepare and support Annual Product Quality Review (APQR / PQR) documentation.
- Initiate and manage Change Controls, Deviations, Incidents, and CAPAs, including investigations and closures.
- Participate in QMS investigations and root cause analysis activities.
- Perform risk assessments for critical manufacturing and quality processes.
- Ensure continuous cGMP compliance and regulatory inspection readiness.
Skills Required
- Strong knowledge of cGMP, QMS, and regulatory compliance.
- Hands-on experience in DS/DP shop floor QA operations.
- Understanding of process validation, cleaning validation, and in-process controls.
- Experience in BMR review and documentation control.
- Strong analytical, investigation, and problem-solving skills.
- Effective communication and cross-functional coordination abilities.
Regulatory Exposure
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USFDA, EMA, WHO, and other global regulatory guidelines (preferred).
Why This Job Role?
This Quality Assurance Job role provides deep exposure to Drug Substance shop-floor QA operations, regulatory audits, validation activities, and quality systems within a growing biopharmaceutical organization, offering strong long-term career progression in Quality Assurance. Graduates seeking M Pharma jobs or Pharmacy jobs can apply now.
