Senior Executive - QA (IPQA - DP)
Enzene Biosciences
- Location
- Pune Division, Maharashtra, India
- Job type
- Full-time
Required skills
- compliance
- cross-functional
- manufacturing operations
- Root Cause Analysis
- batch Records
About the role
Enzene Biosciences
Website:
enzene.com
Job details:
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
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