Independent/Freelance GxP Auditor

2 giorni fa

roma, Italia Altro A tempo pieno

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 AuditsGxP TrainingInspection Readiness Assessment and TrainingInspection Readiness Visits to Investigator Sites for Client-specific contracted projectsMock Regulatory Inspections at Client facilitiesQuality Tool Development (Storyboards)GxP SOP Gap AnalysesGxP SOP DevelopmentRequirements EducationBachelor’s Degree or four (4) years equivalent experienceExperienceMinimum 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 AssuranceKnowledge/Skills/Abilities Strong GxP knowledge; (i.e., GCP, GCLP, GLP, GMP, GVP, CSV)Proficient in the use of Microsoft OfficeFamiliarity with industry specific software and systems used in research and developmentCollaboration with internal and external partners to include understanding client requirements and deliverablesAbility to communicate clearly and professionally in English (verbal, written, and presentation)Seniority level Not ApplicableEmployment type ContractJob function Writing/Editing and ConsultingIndustries: Business Consulting and Services#J-18808-Ljbffr

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