Lead Auditor GCP (m/f)

REFERENZNUMMER:

284608/11

IHRE AUFGABEN:

-Carry out audits and write reports as per assigned timelines
-Identify/handle non-conformances pro-actively
-Ensure that program audit plans are covered by Clinical budget
-Provide GCP oversight and support Clinical Development programs
-Review and approve critical study documents (e.g. protocol)
-Supervision of specific risked-based audit plans, review resulting CAPAs, request additional audits as required (e.g. potential data integrity issues)
-Act as auditor/audit report reviewer and CAPA reviewer in other clinical programs as assigned
-Ensure QA CRO oversight
-Support QA GOP review, ideally study specific GCP training

IHRE QUALIFIKATIONEN:

-Degree in Life Sciences, pharmaceutical/nursing/medicine or other related science or equivalent experience
-Clinical Auditing experience, knowledge regarding GCP/ICH guidelines
-In-depth experience in Clinical Quality Assurance
-Good knowledge of global regulatory framework for Phase II-III studies
-Work experience in a clinical development department (e.g. as Lead CRA, project manager)
-Experience with managing authority inspections is desirable
-Good communication and negotiation skills
-Fluency in English, in both written and verbal form

WEITERE QUALIFIKATIONEN:

Auditor