Upsilon Global

Greece - GCP Quality Assurance & Auditor (QA GCP) – homebased

Location
Greece (GR)
Salary
Hourly rate
Posted
28 Jan 2021
Closes
27 Feb 2021
Discipline
Quality, Auditor
Hours
Part Time
Contract Type
Contract
Experience Level
Experienced (non-manager)

Freelance/consultant GCP Quality Assurance Auditor (QA GCP) – homebased - Greece

Upsilon Global are currently seeking a freelance QA GCP auditor in Greece. You’ll be working with a growing EEU CRO, expanding their service capabilities and seeking the highest quality standards. This is a crucial position, and we are looking for someone who is confident in small/remote teams, can work directly with the head of clinical operations, CMO and CEO and drive the local QA function forward.

Quick info:

  • Start date: March 2021
  • Contract length: 12 months
  • FTE: Variable, estimated at 0.3/0.4 fte
  • Client type: Small EEU CRO
  • Indication: n/a
  • Location: Home-based, Greece

Main Responsibilities

  • To develop and maintain all company GCP SOPs
  • Coordinate the quality system development application to clinical research processes
  • Cooperate in managing and reviewing SOPs and ensure compliance to GCP standards and local regulations;
  • Provide support in case of:
  • GCP Audit and Regulatory Inspection,
  • Implementation of Clinical Audit Programme
  • Revision and archiving of confidential documentation
  • Prepare together with the Director of Clinical Research, RFPs for potential clients
  • Perform Qualification Visits of clinical service vendors;
  • Perform periodic review of personnel files
  • Accompanying CRAs in oversight visits to centres
  • Perform and manage internal and external Audits (GCP) including Qualification Audit, and QC of documentation related to clinical studies
  • Audit protocols, reports, TMF and study relevant procedures;
  • Coordinate the management of CAPA related to clinical study and to the quality system applied to clinical research;
  • Inform and update staff about changes in legislations and regulatory requirements

Education and Qualifications

  • A BSc or BA degree in a lifescience related field
  • Minimum of 2 years experience
  • CRO experience preferred

Other skills and abilities

  • The ability to communicate effectively in English and Greek
  • Good computer literacy with working knowledge of PCs, Windows and Microsoft Office

For further information on this opportunity and to learn of similar positions, please contact Upsilon Global on +44. (0). 20. 3. 8. 75. 9. 96. 6. or email ‘applications (at) upsilon global (dot) com’