Executive - QA (IPQA - DP)

Enzene Biosciences Ltd; Maharashtra; On-site; INR 600,000 - 900,000; Full time

Job summary

Enzene Biosciences Ltd. seeks an Executive for DPQA/QA to perform DPQA activities, IPQA checks, and line clearance across manufacturing and fill-finish operations. The role emphasizes documentation compliance, data integrity, and regulatory readiness.

The candidate will review logs, BMRs/BPRs, perform audits, and support CAPA, validation, and qualification activities from a QA perspective. 2–5 years experience and M.Sc./M.Pharm are preferred.

Qualifications

• 2 to 5 years of QA experience in DPQA / IPQA.
• Experience in line clearance, IPQA checks, and shop floor monitoring.
• Ability to review logs, GMP documents, and batch records.
• Knowledge of GDP, cGMP, and data integrity.
• Ability for contemporaneous documentation and data integrity compliance.

Responsibilities

• Drug Product (DP) Quality Assurance Activities
• Perform line clearance activities in warehouse, washing, solution preparation, filtration, filling, visual inspection, and packing areas.
• Conduct IPQA checks during manufacturing and packaging operations.
• Ensure contemporaneous documentation practices in data integrity compliance.
• 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 procedures.
• Perform Acceptable Quality Level (AQL) inspections for finished products.
• Review executed BMRs, BPRs, and related documentation.
• IPQA Activities – Fill Finish Operations
• Perform line clearance activities in fill-finish 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 procedures and cGMP.
• Conduct routine IPQA checks in fill-finish operations and follow up on corrective actions.
• Continuous monitoring of aseptic operations in Grade B areas.
• Review GMP documents, logbooks, batch records, environmental monitoring records, and other GMP docs.
• Ensure adherence to SOPs, batch records, and quality standards.

Skills

cGMP

GDP

Data Integrity

IPQA activities

Line clearance

In-process checks

Audit trail review

Documentation

Aseptic manufacturing

Validation support

Education

M.Sc. / M.Pharm

Job description

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 upscale 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.
• Good communication and coordination abilities.