AuxiliaGroup Recruitment are currently hiring a Senior Quality Specialist and dRP on behalf of our client, an established company within the pharmaceutical sector. This is a permanent opportunity based in Dublin.
Role:
* Assist in the development, implementation and maintenance of the Quality Management System.
* Ensure Good Distribution Practice (GDP 2013/C 343/01) and current Health Products Regulatory Authority (HPRA) guidelines (IA-G0046) are adhered to covering all GDP activities performed.
* Assist in ensuring the Quality processes are compliant and well understood across the business through continuous training, retraining and informative communications.
* Ensure that only the relevant authorised product classes are procured from approved suppliers and supplied to approved customers and are covered under the Company's Wholesale Distribution Authorisation.
* Assist in the approval of outsourced service providers and assist in route qualifications of transport providers as planned and required.
* Review, Draft and Approve documentation including change controls, deviations, validation documentation, SOP's etc.
* Complete relevant initial and ongoing Bona Fide checks on suppliers and customers as assigned.
* Ensure and maintain a companywide risk management culture.
* Review and update Quality Technical Agreements as required and ensure Technical Agreements are in place with all suppliers, customers, and outsourced service providers.
* Returns – Identify returns within the supply chain and manage accordingly, reporting same to the RP as they arise, ensuring all returns are held in the secure returns area awaiting their fate, ensuring returns are not made available for sale unless approved by the RP.
* Assess temperature-controlled shipments and provide corresponding quality decision on product.
Requirements:
* 5+ years QA experience in a HPRA/EU GDP regulated environment
* Excellent knowledge of temperature-controlled activities
* Thorough knowledge of Good Distribution Practice and global regulatory requirements.
* Sound awareness and understanding of pharmaceutical WDA business models, especially with regards to quality and regulatory requirements.
* Strong Interpersonal skills and ability to interact constructively with all functions in a matrix organization environment
* Good verbal and written communication skills with well-structured communication and ability to present to various audience levels