QA & PHARMACOVIGILANCE EXECUTIVE

Vrinda International; Mumbai; On-site; INR 360,000 - 440,000; Full time

Job summary

Vrinda International in Mumbai (BKC) seeks a dedicated QA & Pharmacovigilance Executive to uphold product quality and patient safety. The role emphasizes GMP and Schedule M compliance while managing pharmacovigilance activities to safeguard pharmaceutical operations.

The candidate will lead investigations into deviations, manage change control, and oversee AE/ADR reporting, vendor qualifications, and regulatory reporting to ensure adherence to standards.

Qualifications

• 1–3 years of relevant QA and pharmacovigilance experience.
• Strong documentation and records-keeping skills.
• Knowledge of GMP and Schedule M regulations.

Responsibilities

• Prepare and maintain quality documentation and records.
• Lead investigations into deviations and OOS results to find root causes and corrective actions.
• Execute change control procedures for process or system modifications.
• Manage end-to-end handling of product complaints and regulatory reporting.
• Conduct vendor qualification assessments to verify supplier compliance.
• Oversee QA and pharmacovigilance functions per internal protocols and regulatory expectations.
• Monitor GMP and Schedule M compliance across operations.
• Draft, review, and file AE/ADR reports per pharmacovigilance standards.

Skills

QA

Pharmacovigilance

GMP compliance

Documentation

Investigations

Change control

AE/ADR filing

Job description

BKC, Mumbai, India | Posted on 11/04/2026

Job 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

• 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.