GCP Auditor (m/f)

REFERENZNUMMER:

234541/1

IHRE AUFGABEN:

-Planning, conducting, reporting and follow-up of investigative site audits in the area of GCP
-Preparing and updating of audit plans
-Preparing of Risk Based Assessments (RBAs) for the selection of sites to be audited
-Preparing a site audit by using the information in the respective systems (IMPACT, EDC-, IRT-, Lab-System)
-Drafting and finalizing the audit report in Trackwise
-Effectively communicating audit results, both orally and in writing
-Reviewing and approving of Corrective Actions Preventative Actions (CAPAs)
-Archiving of audit relevant documents
-Coordination of external auditors
-Supporting clinical study teams in GCP relevant questions through the conduct of clinical trials including study team meeting attendance
-Attendance and presentation at investigator meetings
-Planning, conducting, reporting and follow-up of pre-regulatory inspection assessments
-Preparing and supporting clinical teams in case of regulatory inspections
-Supporting global Inspection Management during a regulatory inspection
-Assisting affiliate audits
-Assisting internal system audits
-Assisting SOP development and revision

IHRE QUALIFIKATIONEN:

-Bachelors Degree in a physical science, life science, nursing, pharmacy or equivalent experience required
-Profound experience in a pharmaceutical company or Contract Research Organization (CRO) required
-Experience in Quality Assurance or Regulatory Affairs
-Experience in clinical research
-Auditing experience (GCP auditing preferred)
-Strong understanding of global GCP requirements
-Good English and German knowledge, both orally and in writing
-Ability to manage and prioritize multiple tasks
-Proactive and positive team player
-Ability to travel

WEITERE QUALIFIKATIONEN:

Auditor