Senior Executive - QA (IPQA - DP)

Enzene Biosciences Ltd; Maharashtra; On-site; INR 900,000 - 1,300,000; Full time

Job summary

Enzene Biosciences Ltd in India is seeking a Senior Executive – DPQA to drive quality assurance across APQR and IPQA activities. The role focuses on maintaining data integrity, adhering to cGMP, and supporting manufacturing quality control.

The candidate will review BMR/BPR, approve SOPs and validation documents, and lead CAPAs and investigations with cross-functional teams. A strong QA background and experience in APQR are essential.

Qualifications

• Strong knowledge of cGMP, GDP and data integrity within pharma QA.
• Experience with APQR/PQR, trend analysis and CAPA processes.
• Expertise in IPQA, in-process controls, and line monitoring.

Responsibilities

• Prepare and maintain APQR schedules and perform trend analysis of CPPs and CQAs.
• Review BMR/BPR, batch records, SOPs, and validation documents.
• Lead CAPAs, investigations, and root-cause analysis for quality events.
• Ensure compliance with GMP regulations, data integrity, and QA procedures.
• Participate in Process Validation, Cleaning Validation, and Media Fill studies.
• Support audits, documentation readiness, and regulatory inspections.

Skills

cGMP knowledge

Data Integrity

IPQA

Root cause analysis

CAPA handling

Investigation skills

Documentation

Analytical skills

Cross-functional coordination

Audit readiness

Education

M.Sc. / M.Pharm

Tools

MS Office

Quality documentation systems

Job description

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

• Strong 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