Position: Senior Executive – DPQA

Department: Quality Assurance (QA)

Experience: 6 to 9 Years

Qualification: M.Sc. / M.Pharm

Key Responsibilities

- Annual Product Quality Review (APQR)

- Prepare and maintain the Annual Product Quality Review (APQR) schedule.

- Ensure timely preparation and completion of APQRs as per the approved schedule.

- Perform trend analysis of Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs).

- Analyze quality data and identify improvement opportunities.

- Recommend, track, and implement Corrective and Preventive Actions (CAPAs) based on APQR findings.

- Ensure compliance with regulatory and internal quality requirements during APQR preparation.

- In-Process Quality Assurance (IPQA)

- Monitor all aspects of manufacturing, processing, packing, and packaging operations.

- Ensure compliance with approved procedures, cGMP requirements, and data integrity practices.

- Perform line clearance, in-process checks, and stage-wise monitoring activities.

- Conduct sampling for in-process and finished products as per approved procedures.

- Participate in Process Validation, Cleaning Validation, and Media Fill activities.

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

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

- Document Review &
- Quality Systems

- Review executed Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR).

- Review and approve quality documents, including:

- Standard Operating Procedures (SOPs)

- Validation Protocols and Sampling Plans

- Investigation Reports

- Discrepancies and Deviations

- Change Controls

- CAPAs

- Market Complaints

- Master Batch Records (BMR/BPR)

- Ensure compliance of documentation with current GMP and regulatory requirements.





- Support audit readiness and documentation compliance activities.

- Complaint Handling &

- Investigations

- Handle product quality complaints received from the market.

- Conduct investigations related to Market Complaints and Adverse Drug Events.

- Prepare investigation reports with root cause analysis and recommendations.

- Initiate and monitor CAPAs arising from complaint investigations.

- Ensure timely closure of investigations and compliance with regulatory expectations.

- Validation &

- Compliance Activities

- Participate in Process Validation, Cleaning Validation, and Media Fill studies.

- Review validation documents, reports, and related quality records.

- Support qualification and validation activities from a QA perspective.

- Ensure compliance with current GMP, regulatory guidelines, and internal quality systems.

- Continuous Improvement

- Identify quality improvement opportunities through trend analysis and investigation outcomes.

- Drive implementation and effectiveness verification of CAPAs.

- Support quality culture initiatives and compliance enhancement programs.

- Participate in internal and external audits and regulatory inspections.

Required Skills &

- Competencies

- Robust knowledge of cGMP, GDP, Data Integrity, and pharmaceutical quality systems.

- Sound understanding of APQR/PQR requirements and trend analysis.

- Expertise in IPQA activities, in-process controls, and line monitoring.

- Knowledge of investigations, deviations, CAPA, change control, and complaint handling.

- Familiarity with Process Validation, Cleaning Validation, and Media Fill activities.

- Good documentation, analytical, and problem-solving skills.

- Strong communication and cross-functional coordination abilities.

- Proficiency in MS Office applications and quality documentation systems

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