Location: Cork Role: Contract Contract Length: 9-12 months
Contract opportunity to join a leading pharma company as the Quality Distribution Specialist responsible for ensuring Good Distribution Practices (GDP) compliance as it relates to the supply of drug products from Ireland, commercial distributors and Access Operations & Emerging Markets (AOEM) distributors.
Support initial due diligence checks of potential new AOEM distributors
Provide routine support topartners in the area of GDP compliance
Generate and maintain Quality Agreements between company and 3rd party Distributors
Documentation review & approval for in-market GMP/GDP activities performed by 3rd parties
Generate and update controlled documents (e.g., procedures, forms, reports) as needed, to ensure compliance with applicable quality objectives and regulatory requirements.
Perform & Support gap analysis and risk assessments on processes to evaluate compliance to relevant GDP regulations/guidelines & implement/support the implementation of corrective actions
Lead and/or participate in small cross-functional working groups to deliver processes & procedures under the Corporate Support Model initiative for the EU and ROW Affiliates
Maintains programs and processes to ensure high quality products delivered to customers and compliance with current Good Distribution Practices (GDPs).
Collaborate cross-functionally with local and global colleagues (Supply Chain, Commercial Operations, Corporate Quality, Customer Service) to identify and implement process improvements in distribution of raw materials and finished products
Participate in developing & delivering training as it pertains to GDP
Participate in internal and external compliance audits as required, including audits of potential new distributors and on-site visits.
Demonstrates proficiency in Good Distribution Practices (GDP) and Good Manufacturing Practices (GMP)
Familiar with the concepts of supply chain dynamics between freight forwarders, carriers and handlers related to the supply and delivery of pharmaceutical materials.
Understands the time & temperature sensitivity of pharmaceutical material and concepts related to product stability, product labelling and risk management.
Demonstrates excellent knowledge of regulations and guidelines associated with distribution supply chain of medicinal products and APIs
Demonstrates proficiency in application of QA principles, concepts, industry practices, and standards.
Demonstrates understanding of international quality systems regulations to adopt best in class systems/processes