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Freelance/Independent GxP Consultant

2 months ago

Canada Advarra Full time

About Advarra Consulting

Advarra Consulting is a leading provider of GxP services, dedicated to supporting the quality and compliance needs of our clients in the pharmaceutical, biotech, medical device, and life science industries.

Job Summary

We are seeking highly experienced and skilled Independent GxP auditors/experts to join our team of consultants. As an Independent GxP auditor/consultant, you will have the opportunity to work on a variety of projects, including:

  • Investigator Site Audits
  • CRO Audits
  • Vendor Audits
  • GxP Training
  • Inspection Readiness Assessment and Training
  • Inspection Readiness Visits to Investigator Sites
  • Mock Regulatory Inspections at Client facilities
  • Inspection Support at Client facilities
  • GxP SOP Gap Analysis
  • GxP SOP Development

Responsibilities

As an Independent GxP auditor/consultant, your responsibilities will include:

  • Conducting audits and assessments of investigator sites, CROs, vendors, and other stakeholders
  • Providing GxP training and support to clients
  • Assisting clients with inspection readiness and mock inspections
  • Developing and implementing GxP SOPs
  • Conducting GxP gap analyses and providing recommendations for improvement

Requirements

To be considered for this role, you will need to have:

  • A Bachelor's Degree in Nursing, Science, or a related field (or equivalent)
  • Minimum of ten (10) years clinical research and/or R&D experience in the pharmaceutical, biotech, medical device, and life science industries
  • Minimum of four (4) years working knowledge and experience in Quality Assurance
  • Strong GxP knowledge, including GCP, GLP, GLP, and GVP
  • Excellent writing and communication skills
  • Computer skills in WORD, EXCEL, and PowerPoint
  • Familiarity with industry-specific software and systems used in research and development
  • Ability to work independently
  • English: Spoken, Written, and Read - Excellent

What We Offer

As an Independent GxP auditor/consultant with Advarra Consulting, you will have the opportunity to work on a variety of projects, develop your skills and expertise, and contribute to the success of our clients. We offer a competitive compensation package and a collaborative and dynamic work environment.