Summary We are seeking a dedicated QA & Pharmacovigilance Executive to join our IT Services division, where you will play a pivotal role in upholding the highest standards of quality and patient safety. This position is essential for ensuring rigorous compliance with regulatory frameworks while managing critical quality documentation and reporting processes. The ideal candidate will bridge the gap between technical quality assurance and pharmacovigilance activities, contributing significantly to the integrity of our pharmaceutical data and operational workflows. Responsibilities
• Conduct comprehensive internal audits and ensure strict adherence to pharmacovigilance compliance protocols.
• Execute product verification procedures and manage the end-to-end handling of customer complaints.
• Oversee deviation management and implement effective change control measures to maintain process integrity.
• Prepare, review, and maintain accurate quality documentation in alignment with industry standards.
• Utilize MS Office tools to generate reports and facilitate data analysis for quality metrics.
• Apply specialized knowledge of Quality Assurance within the pharmaceutical and PV sectors to drive continuous improvement.
• Manage the timely and accurate reporting of Adverse Events (AE) and Adverse Drug Reactions (ADR) to relevant authorities.
• Ensure all operations comply with Good Manufacturing Practices (GMP) and Schedule M regulations. Requirements
Requirements:
• Possess a minimum of 1 year and a maximum of 3 years of relevant professional experience in quality or pharmacovigilance roles.
• Demonstrate proven expertise in internal auditing, PV compliance, and deviation/change control mechanisms.
• Show solid proficiency in product verification, complaint management, and quality documentation practices.
• Hold a solid understanding of Quality Assurance principles specific to the Pharma and PV industries.
• Be well-versed in AE/ADR reporting protocols and regulatory requirements.
• Maintain up-to-date knowledge of GMP standards and Schedule M guidelines.
• Exhibit advanced skills in using MS Office applications for daily tasks and reporting.
• Possess the ability to work effectively within the IT Services sector while managing pharmaceutical quality expectations.