Independent/Freelance GxP Auditor (GCP, GMP, GLP, GVP, CSV)

Advarra; Roma; In loco; EUR 90.000 - 150.000; Part-time

Descrizione del lavoro

A leading consulting firm seeks experienced independent GxP auditors in Rome. The role demands extensive experience in clinical research and quality assurance, focusing on audits and training across GxP domains. Ideal candidates will have a Bachelor's degree and significant experience in life sciences. This is a contract position offering the opportunity to work with a variety of clients.

Competenze

• Minimum of ten years of clinical research and/or R&D experience in life sciences.
• Minimum of seven years experience in Quality Assurance.
• Minimum of seven (7) years working knowledge and experience in Quality Assurance.
• Strong GxP knowledge; (i.e., GCP, GCLP, GLP, GMP, GVP, CSV).
• Proficient in the use of Microsoft Office and familiar with industry software used in research and development.

Mansioni

• Conduct independent audits across GxP domains.
• Provide GxP training and inspection readiness assessments.
• Develop quality tools and perform gap analyses.
• 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)
• GxP SOP Gap Analyses
• GxP SOP Development

Conoscenze

Strong GxP knowledge

Proficient in Microsoft Office

Familiarity with industry-specific software

Clear communication in English

Formazione

Bachelor’s Degree or equivalent experience

Descrizione del lavoro

Overview

Advarra Consulting seeks independent GxP auditors with experience in clinical research, quality assurance, and related life sciences to perform independent audits across GxP domains (GCP, GCLP, GLP, GMP, GVP, CSV).

Responsibilities

• Auditor Engagements (may include any of the following)
• CRO 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)
• 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)

Seniority level

• Not Applicable

Employment type

• Contract

Job function

• Writing/Editing and Consulting
• Industries: Business Consulting and Services