02 set - Roma
Advarra
Overview
Advarra Consulting seeks independent GxP auditors with experience in clinical research, quality assurance, and related life sciences to perform independent audits across GxP domains (GCP, GCLP, GLP, GMP, GVP, CSV).
Responsibilities
- Auditor Engagements (may include any of the following)
- CRO Audits
- GxP Training
- Inspection Readiness Assessment and Training
- Inspection Readiness Visits to Investigator Sites for Client-specific contracted projects
- Mock Regulatory Inspections at Client facilities
- Quality Tool Development (Storyboards)
- GxP SOP Gap Analyses
- GxP SOP Development
Requirements
Education
- Bachelor’s Degree or four (4) years equivalent experience
Experience
- Minimum of ten (10) years clinical research and/or R & D experience in pharmaceutical, biotech, medical device and other life science industries.
- Minimum of seven (7)
years working knowledge and experience in Quality Assurance
Knowledge/Skills/Abilities
- Strong GxP knowledge; (i.e., GCP, GCLP, GLP, GMP, GVP, CSV)
- Proficient in the use of Microsoft Office
- Familiarity with industry specific software and systems used in research and development
- Collaboration with internal and external partners to include understanding client requirements and deliverables
Ability to communicate clearly and professionally in English (verbal, written, and presentation)
Seniority level
- Not Applicable
Employment type
- Contract
Job function
- Writing/Editing and Consulting
- Industries: Business Consulting and Services
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