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Vrinda International

QA & PHARMACOVIGILANCE EXECUTIVE

Vrinda International Mumbai, Maharashtra, India · ₹400K/yr

Human Resources Services · 11-50 employees

3 d ago
qa Mid (2-5 yrs) Full-time India
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About the role

Maintain quality documentation and records, investigate deviations and out-of-specification results, manage change controls and product complaints, and qualify vendors. Oversee quality assurance and pharmacovigilance compliance with GMP and Schedule M requirements, including preparing and submitting adverse event and adverse drug reaction reports.

What they look for

Quality Assurance Pharmacovigilance Quality Documentation Record Keeping Deviation Investigation Out-of-Specification Investigation Root Cause Analysis Corrective Actions Change Control Product Complaint Management Vendor Qualification Good Manufacturing Practices Schedule M Compliance Adverse Event Reporting Adverse Drug Reaction Reporting Regulatory Compliance

Requirements

Requires 1–3 years of relevant pharmaceutical or healthcare experience, with demonstrated capability in quality assurance and pharmacovigilance. Candidates should understand GMP and Schedule M and have experience with investigations, change control, complaints, vendor qualification, documentation, and AE/ADR reporting.

Full description

QA & Pharmacovigilance Executive

Summary

We are seeking a dedicated QA & Pharmacovigilance Executive to join our IT Services team. In this pivotal role, you will be responsible for upholding the highest standards of product quality and patient safety. Your expertise will ensure strict adherence to Good Manufacturing Practices (GMP) and Schedule M regulations while managing critical pharmacovigilance activities. This position is essential for maintaining regulatory compliance, driving continuous improvement in quality systems, and safeguarding the integrity of our pharmaceutical operations.

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.

Requirements

Requirements:

  • 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.

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