Senior Quality Specialist

IrishJobs

Dublin, Dublin, Ireland

Dublin, Dublin, Ireland

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Job Description: Our client a leading pharmaceutical company is currently recruiting for a Senior Quality Specialist Role Overview Candidate is responsible for the quality oversight of the distribution of products within our clients Solutions Supply Chain. Position ensures product shipments are managed in compliance with GDP requirements and applicable solutions procedures. Position supports Logistics, Customer Service and Commercial functions. Experience / Qualifications Required 5+ years QA experience in a HPRA/EU GDP regulated environment. Thorough knowledge of temperature-controlled activities. Thorough knowledge of Good Distribution Practice and global regulatory requirements in respect to the wholesaling of medicinal products. 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 Previous experience working within a pharmaceutical wholesaler business, preferable. Previous experience working with Medical Devices, desirable but not required. Key Responsibilities Day-to-day responsibilities include but are not limited to the following. 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 all staff are initially trained upon commencement of employment and that a continuous training program is in place for all current and new employees. Ensure that only the relevant authorised product classes are procured from approved suppliers and supplied to approved customers and are covered under the Companys 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 Implement documentation including change controls, deviations, validation documentation, SOPs 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. Escalate any known or suspected Adverse Reactions (ADRs) and or serious Product Quality defects to the RP for onward reporting to the relevant Competent Authority and the relevant Product Authorisation holder as applicable. Recalls ensure coordination and actioning of any recall activity for medicinal products are conducted immediately upon notification within a controlled and compliant manner. Act as dRP on the clients Solutions Wholesale Authorisation and fulfil all the responsibilities and duties on behalf of the RP in their absence and ensure that a handover of information is completed prior to the absence and the returning of the named RP to work. Conduct any duties required as delegated to the dRP from the RP, keeping all records of these duties and activities appropriately recorded. Ensure that continuity of supply is maintained but ensure that no commercial decision made has any impact on the quality/patient/product safety. Escalate any known or suspected Falsified Medicines to relevant Competent Authorities and relevant product authorization holder as soon as possible. Ensure that a key focus is maintained at all times on the accuracy of the quality records within the client Solutions Quality Management System and related GDP systems. Carry out duties / projects as assigned by the Quality Manager and Responsible Person.

TLNT1_IJ

Dublin, Dublin, Ireland

Sprachkenntnisse

English

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