I am working with a global pharmaceutical organisation based in East Cork that has a permanent opportunity for a Compliance Specialist. If you are excited by working on multiple diverse projects this could be an excellent fit....(blended approach of working from home (2 days) and on site (3 days) available).
· Ensure Quality Management System compliance with EU and local Market Authorization Holder (MAH) requirements
· Complete Product Quality Review (PQR) as per schedule
· Ensure any subcontracted activities which may impact on GDP are assessed and suppliers/ customers approved
· Ensure the review, and where appropriate, preparation and regular update of Quality Agreements and Service Agreements with licensees and 3rd party contractors
· Attend Management Reviews to participate in the review of the effectiveness of Quality and Compliance Policy and Objectives in the context of the WDA
· Minimum 3 years in international pharmaceutical and/or biotech industry
· Preferably a minimum 3 years of experience in GDP / RP role
· Thorough understanding of pharmaceutical business, especially with regard to quality, supply chain and regulatory requirements.
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.
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