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Senior Executive - QA (IPQA - DP)

enzene biosciences ltd
6-9 Years
Pune, India
Early Applicant
  • Posted a month ago
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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

More Info

Job Type:
Permanent Job
Industry:
Other
Function:
Quality Assurance
Employment Type:
Full time

Job ID: 151730243

Last Updated: 29-07-2026 06:00:31 PM
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