GCP Auditor

My client is a GXP Quality Assurance consultancy, working with a variety of global pharmaceutical, biotechnology and healthcare clients across the EMEA region.

They are seeking an experienced GCP Auditor to join their team in Europe. This is a 100% remote role, with the majority of work home-based, and travel required to client sites to audit.

The role can be offered on a permanent or consultancy/B2B basis, depending on your needs. The salary/rate is highly competitive and negotiable based on experience.

Responsibilities:

• Perform GCP quality assurance projects on behalf of client companies within the pharmaceutical industry
• Contribute to upskilling of consultants in the conduct of vendor and systems audits
• Actively participate in the LMS
• Assist with business development activities
• Perform other reasonable duties as requested by the job holder’s Line Manager
• Leading, planning, conducting, documenting and following-up of global GCP audits according to applicable regulations, standards, quality agreements, and guidance documents
• Maintaining current knowledge of regulations, standards, guidance documents, industry initiatives and trend that impact GCP

Requirements:

• BSc in Life Science Preferred
• Experience in conducting and leading internal and external GCP audits for a variety of stakeholders
• Experience in conducting a range of service provider audits (e.g., full service CRO, biostatistics, data management, phase I)
• Experience in conducting GCP systems audits
• Experience in coordinating and managing inspection preparation activities for GCP process inspections both at the sponsor and investigator site
• Experience in conducting GCP mock inspections to Competent Authority standard considered a significant advantage
• Expert knowledge of national and international GCP legislation and guidelines
• Proficient in managing projects and ensuring deliverables are provided on time
• Ability to identify issues and offer solutions in a pragmatic way

Other Requirements:

• Strong communication skills
• Excellent writing skills
• Positivity, flexibility, and adaptability
• Highly professional and self-motivated
• Ability to work independently in a home office setting
• Confidence to work alone or in team
• Up to 40% travel and ability to conduct remote audits

This is an opportunity for an ambitious individual who is looking to serve as an industry expert, gain international experience and broaden their skills whilst being home-based. They offer a competitive salary with benefits, excellent working conditions and a fulfilling and rewarding career, with plenty of opportunities for further development.
 

If you have the essential skills required and would like to discuss the full detail of the Job Description, required competencies, and remuneration, please contact Katie Dunbar on +441293 584300, or apply with your CV to arrange a confidential discussion.