Pharmaceutical Quality GMP Auditor – Consulting
Advarra
part-time
Posted on:
Location Type: Remote
Location: Japan
Visit company websiteExplore more
About the role
- Conduct Good Manufacturing Practice (GMP) 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 Manufacturing Practice (GMP) experience.
- Minimum 5+ years of Good Manufacturing Practice (GMP) 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
- B2 level in Japanese communication, verbal and written
- Bachelor's degree
Benefits
- N/A 📊 Check your resume score for this job Improve your chances of getting an interview by checking your resume score before you apply. Check Resume Score
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Good Manufacturing Practice (GMP) auditingaudit report writingregulatory agency compliancequality assurance plansaudit programscorrective action plans
Soft Skills
collaborative workcommunicationpresentation skills