Teva Pharmaceuticals USA, Inc.

CQA Auditor III, GCP

US-PA-Great Valley
Requisition #
17-20296
# Positions
1
Experience (Years)
3
Category
Quality - Quality Assurance

Overview

We are seeking a Clinical Quality Auditor to support of Teva's Branded Pharmaceutical Products R&D business.

Responsibilities

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

 

Qualifications

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 

 

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