QUALITY ASSURANCE & PHARMACOVIGILANCE
Posted Updated
Description
Quality Assurance & Pharmacovigilance Specialist
Summary
We are seeking a dedicated professional to oversee the integrity and safety standards of our pharmaceutical and IT service operations. This pivotal role is responsible for ensuring that all products and processes adhere to rigorous regulatory frameworks and internal quality protocols. The successful candidate will play a critical part in maintaining compliance, managing risk, and driving continuous improvement initiatives to safeguard patient safety and product efficacy throughout the lifecycle.
Responsibilities
- Conduct thorough product verification processes to ensure accuracy and compliance with established standards.
- Execute internal audits to evaluate operational effectiveness and identify areas for potential improvement.
- Manage change control procedures, assessing the impact of modifications and ensuring proper documentation.
- Oversee complaint management systems, investigating reports and coordinating resolutions efficiently.
- Uphold Quality Assurance principles across all departments to maintain high operational standards.
- Perform Pharmacovigilance activities, including the detection, assessment, understanding, and prevention of adverse effects.
- Develop, implement, and maintain Standard Operating Procedures (SOPs) to guide daily operations.
- Lead Corrective and Preventive Action (CAPA) initiatives to address root causes of non-conformities.
- Ensure strict adherence to Good Manufacturing Practices (GMP) in all relevant activities.
Requirements
Requirements:
- Possess a minimum of 1 to 3 years of relevant professional experience in the field.
- Demonstrate strong proficiency in Product Verification and Internal Audits.
- Show expertise in managing Change Control and Complaint Management systems.
- Have a solid background in Quality Assurance and Pharmacovigilance methodologies.
- Be well-versed in creating and enforcing SOPs, CAPA processes, and GMP regulations.
- Ability to work within the IT Services sector with a focus on pharmaceutical quality standards.
- Competitive salary package of ₹4 LPA commensurate with experience.