Upsilon Global

Freelance Clinical and QA Auditor, Italy

Location
Italy (IT)
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 - Italy

Upsilon Global are currently seeking a freelance QA GCP auditor in Italy. 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, Italy

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 Italian
  • 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) upsilonglobal (dot) com’