GCP Auditor (EMEA)

by | Career Opportunities

ADAMAS Consulting LTD
This is an immediate, full-time employment 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.

ADAMAS’s success is down to the calibre of its people – to reward them we offer a competitive salary with benefits, excellent working conditions and a fulfilling and rewarding career, with plenty of opportunities for further development.

ADAMAS Consulting LTD is an independent provider of GXP Quality Assurance services to the pharmaceutical, biotechnology and healthcare industries. ADAMAS Consulting LTD, established in 1997, is the fully owned subsidiary of ADAMAS Consulting Group Ltd based in the UK and providing services in Europe, the Middle East, and Africa.

 

Responsibilities:

  • Perform GCP quality assurance projects which fall within the job holder’s areas of expertise 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 ADAMAS Learning Management System
  • 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

 

What ADAMAS can offer you:

  • Competitive salary
  • 25 paid vacation days
  • Working from home
  • Flexible working hours
  • Pension contribution
  • Additional benefits

 
If you like the prospect of a home-based role, flexible working conditions, excellent benefits and of course the opportunity to further your career within an exciting organization, then please submit your CV to Carly Davenport at carly.davenport@adamasconsulting.com.

No unsolicited calls from recruitment agencies please.

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