23 ott - Lazio
Advarra
Overview Advarra Consulting seeks independent Gx P auditors with experience in clinical research, quality assurance, and related life sciences to perform independent audits across Gx P domains (GCP, GCLP, GLP, GMP, GVP, CSV).
Responsibilities
Auditor Engagements (may include any of the following) CRO Audits Gx P 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) Gx P SOP Gap Analyses Gx P 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 Gx P 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