What are the responsibilities and job description for the GVP Auditor position at Actalent?
Description:
Key areas of accountability for this role are to provide professional expertise and strong technical leadership in GVP and GCP and applicable regulations and guidance and to identify compliance issues/risks proactively.
• Contribute to the GVP audit strategy and lead GVP audits
• Prepare GVP audit plans and conduct GVP audits
• Manage GVP audits led by contractors
• Ensure a high level of quality and consistency across the entire audit program
• Develop and conduct and/or host GVP gap assessment, GVP quality assessments, GVP questionnaires and other QA investigations
• Managing or hosting regulatory agency inspections and partner audits
• Act as GVPQA point of contact for Quality Management System Elements as assigned (e.g. review SOPs, training material, contracts, documentation)
• Developing and maintaining GVP SOPs, training programs, inspection readiness support deviation/CAPA management, and metrics reporting such as:
o Develop and review GVP SOPs
o Develop and coordinate GVPTraining
o Support regulatory inspection readiness activities
• Enhancing GVP QA infrastructure and procedures
• Reviewing consistency with RDQ processes and procedures
• Triaging and escalating major risks/areas of exposure to sr management
• Oversee and manage the GVP Deviation and CAPA management process using Veeva
Additional Skills & Qualifications:
• Minimum Bachelor’s degree in life sciences is required or equivalent.
• A minimum of 7 years of GVP auditing experience and a minimum of 10 years in pharmaceutical industry is required.
• Knowledge of the drug development process, including Good Pharmacovigilance Practice, Good Clinical Practices (GCPs), FDA Code of Federal Regulations, national and international Pharmacovigilance legislation and guidelines
• Experience in conducting and leading internal and external Pharmacovigilance audits for a variety of stakeholders
• Understanding of good documentation practices, ability to organize and utilize electronic systems to track and manage information
• Experience with effectively managing pharmacovigilance regulatory inspections, working with regulators and partner audits
• Experience with Veeva is desired
• Must have excellent communication skills (verbal and written)
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
- Hiring diverse talent
- Maintaining an inclusive environment through persistent self-reflection
- Building a culture of care, engagement, and recognition with clear outcomes
- Ensuring growth opportunities for our people
Actalent is an equal opportunity employer.
About Actalent
Actalent connects passion with purpose. We help visionary companies advance their engineering and science initiatives through access to specialized experts that drive scale, innovation, and speed to market. With a network of almost 30,000 engineering and sciences consultants and more than 4,500 clients across the U.S., Canada, Asia, and Europe, Actalent serves many of the Fortune 500. An operating company of Allegis Group, the global leader in talent solutions, Actalent launched as a new specialized engineering and sciences services and workforce solutions brand in 2021.
Salary : $100
