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Job Description
PURPOSE:
Manages QAS projects for the delivery of QA GVP services to Clients, in full compliance with the applicable GVP Legislation, Client’s requirements and the Regulatory Business Quality Standards.
Requirements
ACCOUNTABILITIES:
* Prepares and performs audits on behalf of clients, and relevant reporting to them.
* Assists clients in supporting their Annual Audit plan.
* Collaborates with the QA Director to manage the external Auditors and engage them as appropriate.
* Develops the workflow and operational planning for the QA GVP Services provided.
* Ensures that Quality & Projects Plans are developed according to client requirements.
* Ensures oversight for day-to-day interactions with all staff involved in the services delivery.
* Develops standard operating procedures and work guidance and/or reviews Client’s SOPs if applicable, to ensure full compliance.
* Contributes to GVP quality management plans and compliance program.
* Assists clients in audit/inspection readiness.
* Ensures tracking of compliance metrics.
* Assists clients in identifying and following up on corrective action plans arising from audits and inspections.
PROFESSIONAL BACKGROUND & EXPERIENCE:
* Bachelor's degree in life science disciplines.
* At least 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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