
Clinical Quality Assurance Expert
20 hours ago
This role involves overseeing end-to-end clinical trial activities from a quality assurance perspective, ensuring timely completion of tasks and maintaining high standards.
- Ensure constant readiness for inspections and audits by reviewing all study-related activities, processes, and procedures.
- Develop and implement a risk-based approach to quality compliance within the function.
- Identify and decide on team member job-specific SOP training requirements.
- Prepare and review SOPs related to QC functions.
- Quality review of clinical trial medical science and operation-related activities.
Requirements:
- 5 years' experience in a pharmaceutical or biotech organization in the quality department.
- Strong attention to detail with an ability to identify inconsistencies.
- Thorough knowledge of recent GCP guidelines, ICMR guidelines, and Drugs and Cosmetic Act regulations.
The ideal candidate should have excellent conflict management skills and a strong track record of success demonstrated through annual performance ratings and professional accomplishments.
This role requires safeguarding human subjects from research risks, data reliability and integrity, internal consistency, and quality compliance measures.
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