Responsible Person

Posted 3 hours 49 minutes ago by Walker Cole International Ltd

74 100,00 € - 82 800,00 € Annual
Permanent
Full Time
Other
Dublin, Ireland
Job Description
Walker Cole International is partnering with a global pharmaceutical organisation to appoint a Responsible Person (RP) to take ownership of GDP compliance and Quality oversight across their wholesale distribution activities in Ireland and Europe. This is a key leadership position, working closely with senior management to ensure full regulatory compliance and the safe distribution of medicinal products across multiple markets. As a Responsible Person, you will be responsible for: Ensuring the Quality Management System (QMS) is implemented, maintained, and continuously improved in line with EU GDP guidelines and applicable regulations. Maintaining oversight of all wholesale distribution activities, including supplier/customer approval, audits, and ensuring inspection readiness. Leading and managing deviations, CAPAs, change controls, complaints, and recall activities to ensure compliance and patient safety. Acting as the named RP on the Wholesale Distribution Authorisation (WDA), ensuring licence obligations are met and providing regulatory guidance to senior stakeholders. To be successful as a Responsible Person, you will have: Eligibility to act as a named Responsible Person under EU GDP requirements. A degree in Pharmacy, Chemistry, Microbiology, Engineering, or a related scientific discipline. Experience within a GDP-regulated pharmaceutical distribution environment, including oversight responsibilities. Strong knowledge of EU GDP regulations, with experience operating within a Quality Management System and managing audits/inspections. Responsible Person RP GDP Wholesale Distribution WDA Quality Assurance QMS Pharmaceutical Distribution Compliance Audits CAPA Deviations Supplier Qualification Regulatory Inspections EU GDP Supply Chain