Seeking: Independent GxP Consultants - (i.e., GCP, GCLP, GLP, GMP, GVP, CSV)
Advarra Consulting has the responsibility to perform independent audits, covering Good Clinical Practice, Good Laboratory Practice, Good Manufacturing Practice, and Good Pharmacovigilance Practice.
Advarra 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.
Auditor Engagements (may include any of the following)
Investigator Site Audits
CRO Audits
GxP Vendor Audits
GxP 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)
Inspection Support at Client facilities
GxP SOP Gap Analyses
GxP 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 GxP 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)