
Clinical Quality Assurance Compliance Specialist
23 hours ago
This role is responsible for overseeing clinical trial activities from a quality perspective, ensuring adherence to applicable regulations and guidelines. Key responsibilities include reviewing study-related activities, processes, and procedures; developing and implementing risk-based approaches to quality compliance; and preparing SOPs related to QC functions.
Key Responsibilities:- Quality review of clinical trial medical science activities
- Development and implementation of risk-based approaches to quality compliance
- Preparation of SOPs related to QC functions
Required Skills and Qualifications:
- 5+ years of experience in a CRO/Pharma/Biotech organization with Quality department experience
- Strong attention to detail and conflict management skills
- Experience handling audits and inspections (DCGI, US FDA)
- Thorough knowledge of GCP guidelines and other applicable regulations
Benefits:
This role offers the opportunity to work in a matrix business environment and contribute to the success of our organization through effective quality assurance practices.
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