Freelance Gxp Consultant (Gcp, Gclp, Gmp, Glp, Gvp, Csv)

Independent GxP Consultants - (i.e., GCP, GCLP, GLP, GMP, GVP) Status: 1099 Advarra Consulting – GxP Services has the responsibility to perform independent audits and other consulting services as an individual or as part of a larger Team for Advarra Client Projects covering Good Clinical Practice, Good Laboratory Practice, Good Manufacturing Practice, and Good Pharmacovigilance Practice. What we are actively seeking: Independent GXP auditors/experts, who are looking to work with an exciting & diverse Consulting organization to support the quality and compliance needs of our customers. These individuals will professionally apply working knowledge and expertise in clinical research, quality assurance and other diverse areas to effectively provide service and project deliverables.• Global Engagements (as applicable and agreed) o Investigator Site Audits o CRO Audits o Vendor Audits o GxP Training o Inspection Readiness Assessment and Training o Inspection Readiness Visits to Investigator Sites for Client-specific contracted projects o Mock Regulatory Inspections at Client facilities o Inspection Support at Client facilities o GxP SOP Gap Analyses o GxP SOP Development Requirements: 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 four (4) years working knowledge and experience in Quality Assurance Knowledge/Skills/Abilities
• Strong GxP knowledge; (i.e., GCP, GcLP, GLP, GMP, GVP) • Excellent writing and communication skills.
• Computer skills in WORD, EXCEL and Power Point;
• Familiarity with industry specific software and systems used in research and development
• Ability to work independently
• English: Spoken, Written and Read - Excellent