Pharmaceutical Quality GCP Auditors, Consulting
Advarra
part-time
Posted on:
Location Type: Hybrid
Location: Ankara • Turkey
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Tech Stack
About the role
- Conduct Good Clinical Practice (GCP) audits (planning, agenda, physical or remote audit, and report writing)
- Evaluate investigator sites, CROs, and vendor compliance or qualification.
- Prepare comprehensive audit reports detailing findings and root-causes.
- Provide written audit reports in English.
- If required will provide corrective actions support and present findings to QA leadership and stakeholders.
- Work collaboratively with clients to ensure quality standards.
Requirements
- Minimum 10+ years of Clinical Quality Assurance and/or Good Clinical Practice (GCP) experience.
- Minimum 5+ years of Good Clinical Practices auditing experience.
- Demonstrated experience with regulatory agency expectations (e.g., FDA, EMA) and audit readiness activities.
- Demonstrated experience in developing and implementing quality assurance plans, audit programs, and corrective action plans.
- B2 level in English communication, verbal and written.
- Bachelor's degree
Benefits
- Flexible work arrangements
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Good Clinical Practice (GCP) auditingaudit report writingregulatory agency compliancequality assurance plansaudit programscorrective action plans
Soft Skills
collaborative workcommunicationpresentation skills