27 ott - Roma
Advarra
ph3Overview /h3pAdvarra 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). /ph3Responsibilities /h3ulliAuditor Engagements (may include any of the following) /liliCRO Audits /liliGxP Training /liliInspection Readiness Assessment and Training /liliInspection Readiness Visits to Investigator Sites for Client-specific contracted projects /liliMock Regulatory Inspections at Client facilities /liliQuality Tool Development (Storyboards) /liliGxP SOP Gap Analyses /liliGxP SOP Development /li /ulh3Requirements /h3pEducation /pulliBachelor’s Degree or four (4) years equivalent experience /li /ulpExperience /pulliMinimum of ten (10) years clinical research and/or R D experience in pharmaceutical, biotech, medical device and other life science industries. /liliMinimum of seven (7)
years working knowledge and experience in Quality Assurance /li /ulh3Knowledge/Skills/Abilities /h3ulliStrong GxP knowledge; (i.e., GCP, GCLP, GLP, GMP, GVP, CSV) /liliProficient in the use of Microsoft Office /liliFamiliarity with industry specific software and systems used in research and development /liliCollaboration with internal and external partners to include understanding client requirements and deliverables /li /ulpAbility to communicate clearly and professionally in English (verbal, written, and presentation) /ph3Seniority level /h3ulliNot Applicable /li /ulh3Employment type /h3ulliContract /li /ulh3Job function /h3ulliWriting/Editing and Consulting /liliIndustries: Business Consulting and Services /li /ul /p #J-18808-Ljbffr
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