Overview
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.
Responsibilities
* 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)
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