PSeeking: Independent GxP Consultants - (i.e., GCP, GCLP, GLP, GMP, GVP, CSV) /ppAdvarra Consulting has the responsibility to perform independent audits, covering Good Clinical Practice, Good Laboratory Practice, Good Manufacturing Practice, and Good Pharmacovigilance Practice. /ppAdvarra is seeking Independent GXP auditors, with experience and expertise in clinical research, quality assurance and other diverse areas to effectively provide service and project deliverables. /pulliAuditor Engagements (may include any of the following) /liliInvestigator Site Audits /liliCRO Audits /liliGxP Vendor 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) /liliInspection Support at Client facilities /liliGxP SOP Gap Analyses /liliGxP SOP Development /li /ulpRequirements /ppEducation /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 /ulpKnowledge/Skills/Abilities /pulliStrong 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) /p