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Job Description PURPOSE:
Manages QAS projectsfor the delivery of QA GVP services to Clients, in full compliance with theapplicable GVP Legislation, Client’s requirements and the Regulatory Business QualityStandards.
Requirements ACCOUNTABILITIES:
Prepares and performsaudits on behalf of clients, and relevant reporting to them
Assist clients insupporting their Annual Audit plan
Collaborate with the QADirector to manage the external Auditors and engage them as appropriate
Develops the workflowand operational planning for the QA GVP Services provided
Ensures that Quality& Projects Plans, are developed according to client requirements
Ensures oversight forday-to-day interactions with all staff involved in the services delivery
Develops standardoperating procedures and work guidance and/or reviews Client’s SOPs ifapplicable, to ensure full compliance
Contributes to GVPquality management plans and compliance program
Assists clients inaudit/inspection readiness
Ensures tracking ofcompliance metrics
Assistsclients in identifying and up following up on corrective action plans arisingfrom audits and inspections
PROFESSIONAL BAKGROUND & EXPERIENCE
Bachelor's degree in lifescience disciplines
Atleast 5 years of experience as a GVP QA Consultant and Auditor
English, Very good/Fluent
GVP regulations
Auditing(and related qualification if required)
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