We are seeking a Clinical Quality Auditor to support of Teva's Branded Pharmaceutical Products R&D business.
Works with minimal supervision in planning, scheduling and conducting investigational site audits and TMF audits
Works with minimal supervision in reviewing /auditing clinical trial related documents
Assists in the development, review, approval and distribution of global departmental SOP, Work Instructions, forms and templates
Assists in developing training programs with the associated documentation and presentation of such programs
Provides informal guidance to junior staff
Assists in the conduct of internal system audits
Participates in CQA investigations to determine root cause analyses for CAPAs
Participates in the preparation for and during an agency inspection
Participates and attends assigned study teams meetings and provides study team oversight and guidance
Bachelors Degree in Biological Sciences/Health Care or combinition of education and related work experience
Working knowledge of GCPs / ICH / EU Directives/FDA/ etc.
At least 3 years related experience