Related skills
gcp audits edc capa clinical study reports📋 Description
- Audit study, project, and process reports; report QA findings.
- Interact with clients to discuss QA observations and issues.
- Lead quality improvement initiatives for study data and processes.
- Detect quality issues and determine CAPAs; evaluate deviations.
- Assist with client audits and regulatory inspections prep.
- Participate in System and Vendor audits (prep, conduct, follow-up).
🎯 Requirements
- Bachelor’s degree in science, IT, business, or similar
- 2-5 years quality/lab/clinical experience
- Excellent oral and written communication skills
- Ability to organize and manage multiple priorities
- Excellent time management skills
- Attention to detail, tactful, and diplomatic
- Proficiency in using electronic data and computerized systems
- Ability to travel, as needed
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