QA & Pharmacovigilance Executive

Summary

Responsibilities

• Prepare and maintain comprehensive quality documentation and manage essential records with precision.
  
• Lead thorough investigations into process deviations and Out-of-Specification (OOS) results to identify root causes and implement corrective actions.
  
• Execute change control procedures to ensure all modifications to processes or systems are evaluated, approved, and documented appropriately.
  
• Manage the end-to-end handling of product complaints, ensuring timely resolution and regulatory reporting.
  
• Conduct vendor qualification assessments to verify that suppliers meet our rigorous quality and compliance standards.
  
• Oversee Quality Assurance and Pharmacovigilance functions to ensure alignment with internal protocols and external regulatory expectations.
  
• Monitor compliance with GMP guidelines and Schedule M requirements across all operational activities.
  
• Draft, review, and submit Adverse Event (AE) and Adverse Drug Reaction (ADR) reports in strict accordance with pharmacovigilance compliance mandates.
  

• Proven experience in Quality Assurance and Pharmacovigilance within the pharmaceutical or healthcare sector.
  
• Strong proficiency in managing quality documentation and maintaining accurate record-keeping systems.
  
• Demonstrated ability to conduct effective investigations regarding deviations and Out-of-Specification findings.
  
• Solid understanding of Change Control processes and their application in a regulated environment.
  
• Experience in handling product complaints and coordinating with relevant stakeholders for resolution.
  
• Knowledge of vendor qualification processes and supplier assessment methodologies.
  
• In-depth familiarity with Good Manufacturing Practices (GMP) and Schedule M regulations.
  
• Competence in preparing and filing AE/ADR reports while ensuring full compliance with pharmacovigilance standards.
  
• Minimum 1 to 3 years of relevant professional experience.
  
• Compensation package aligned with the market rate of ₹4 LPA.