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18 hours ago
Job Title: Quality Assurance Specialist
This role involves overseeing end-to-end clinical trial activities from a quality perspective, ensuring 24x7 readiness for inspections and audits. The successful candidate will be accountable for compliance with regulatory requirements and best practices.
- Develop and implement risk-based approaches to quality management within the function, safeguarding trial participants and data.
- Identify and decide on training requirements for team members, maintaining oversight to ensure all team members are trained as required.
- Prepare and review standard operating procedures (SOPs) related to quality functions, medical science, and data management.
- Conduct quality reviews of clinical trial-related activities, tools, plans, and documentation.
The ideal candidate has 5+ years of experience in a pharmaceutical or biotechnology organization, specifically in the quality department with experience of quality activities in clinical research departments.
The role requires strong attention to detail, conflict management skills, and thorough knowledge of recent GCP guidelines, ICMR guidelines, and other applicable regulations.
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