Job Title : Executive/ Senior Executive QA (DSQA)

Company: Enzene Biosciences

Location: Pune, Chakan

? Department: Quality Assurance

? Qualification: M.Sc. / M.Pharm. / M.Tech

? Experience: 3-8 Years

About the Role:

This position is responsible for ensuring cGMP compliance across Drug Substance manufacturing operations through effective shop floor quality oversight, documentation review, and quality systems management. The role supports the manufacture of biosimilars and biologics in a globally regulated environment.

Key Responsibilities:

Shop Floor Quality Oversight-

- Perform manufacturing line clearance activities for Drug Substance operations.
- Ensure effective execution and compliance of in-process quality checks during manufacturing.
- Conduct routine GMP and compliance rounds, document observations, and drive timely corrective actions.
- Ensure continuous adherence to cGMP requirements and regulatory expectations on the shop floor.

Documentation & Validation-
- Review online Batch Manufacturing Records (BMRs) for accuracy, completeness, and compliance.
- Review and approve Process Validation and Cleaning Validation protocols and reports.
- Review and manage SOPs, protocols, reports, and other GMP documentation related to manufacturing operations.
- Coordinate sample collection and submission as per BMR requirements, specifications, validation, and stability protocols.

Quality Systems & Compliance-
- Initiate, review, and manage Change Controls, Deviations, Incidents,



and CAPAs, ensuring timely investigation and closure.
- Participate in quality investigations, root cause analysis, and implementation of corrective and preventive actions.
- Perform risk assessments for critical manufacturing and quality processes.
- Support continuous improvement initiatives to strengthen quality systems and operational excellence.

Product Quality & Regulatory Support-
- Prepare and support Annual Product Quality Review (APQR/PQR) activities.
- Ensure inspection readiness and support audits by maintaining robust compliance practices.
- Collaborate with cross-functional teams to maintain a strong quality culture across operations.

Preferred Experience:

- Experience in Biosimilar and/or Biologics manufacturing environments.
- Hands-on exposure to Drug Substance (DS) Shop Floor QA/IPQA activities.
- Experience in Deviations, CAPA, Change Controls, Investigations, and Risk Assessments.
- Knowledge of Process Validation, Cleaning Validation, and regulatory compliance requirements.
- Exposure to USFDA, EMA, WHO, or other global regulatory environments will be preferred.

Why Join Us?

- Opportunity to work in a growing biopharmaceutical organization focused on biosimilars and biologics.
- Exposure to advanced Drug Substance manufacturing operations and global quality standards.
- Collaborative and innovation-driven environment with opportunities for continuous learning and skilled growth.

📌 Executive/ Senior Executive QA - IPQA(DS) (Pune)
🏢 Enzene Biosciences
📍 Pune