Position: Executive – DPQA

Department: Quality Assurance (QA)

Experience: 2 to 5 Years

Qualification: M.Sc. / M.Pharm

Key Responsibilities

- Drug Product (DP) Quality Assurance Activities

- Perform line clearance activities in warehouse, washing, solution preparation, filtration, filling, visual inspection, and packing areas.

- Conduct In-Process Quality Assurance (IPQA) checks during manufacturing and packaging operations.

- Ensure contemporaneous documentation practices in compliance with data integrity requirements.

- Perform audit trail review and user management activities in computerized systems.

- Review logbooks, GMP documents, and operational records for completeness and compliance.

- Carry out sampling activities at various stages of manufacturing and packing processes as per approved procedures.

- Perform Acceptable Quality Level (AQL) inspections for finished products.

- Review executed Batch Manufacturing Records (BMRs), Batch Packaging Records (BPRs), and associated documentation.

- IPQA Activities – Fill Finish Operations

- Perform line clearance activities in fill-finish grade areas, including manufacturing, filtration, filling, sealing, and packaging operations.

- Execute and document in-process quality checks on the fill-finish shop floor.

- Monitor manufacturing and filtration activities to ensure compliance with approved procedures and cGMP requirements.

- Conduct routine IPQA checks in fill-finish operations and follow up on corrective actions for observed deficiencies.

- Perform continuous monitoring of aseptic operations in Grade B manufacturing and filling areas.

- Review logbooks, batch records, environmental monitoring records, and other GMP documents related to shop floor activities.

- Ensure adherence to approved SOPs, batch records, and quality standards during operations.

- Documentation & Compliance





- Review GMP documents, logbooks, protocols, and records for compliance with regulatory requirements.

- Ensure accurate and timely completion of documentation activities.

- Verify compliance with Good Documentation Practices (GDP) and Data Integrity principles.

- Support document control activities and archival of quality records.

- Assist in the review and closure of observations identified during routine QA activities.

- Validation and Qualification Support

- Participate in Media Fill activities and ensure proper execution and documentation.

- Track and update Media Fill schedules and records.

- Support gowning qualification activities and associated documentation.

- Participate in qualification and validation activities from a QA perspective.

- Ensure compliance during validation and qualification studies.

- Quality Systems & Continuous Improvement

- Identify and escalate quality and compliance issues observed during shop floor monitoring.

- Support implementation of corrective and preventive actions (CAPA) arising from QA observations.

- Participate in internal audits, self-inspections, and regulatory audit preparations.

- Contribute to continuous improvement initiatives related to product quality, compliance, and operational excellence.

Required Skills & Competencies

- Good knowledge of cGMP, GDP, and Data Integrity requirements.

- Understanding of aseptic manufacturing and fill-finish operations.

- Experience in IPQA activities, line clearance, in-process checks, and shop floor monitoring.

- Knowledge of batch record review and GMP documentation practices.

- Familiarity with audit trail review and computerized system compliance.

- Understanding of media fill, gowning qualification, and contamination control practices.

- Strong attention to detail and documentation skills.

- Positive communication and coordination abilities.

📌 Executive - QA (IPQA - DP) (Pune)
🏢 Enzene Biosciences
📍 Pune