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Senior QA Specialist Dublin Ireland,  


Posted on : 19 May 2017

Project Description

Reporting to the Director Quality Assurance. Responsible for performing key Quality tasks in respect of Company products. Work in the Quality Group within the Technical Operations department, which oversees contract manufacturing operations, select supply chain operations and development functions. Responsibilities:Responsible for developing and maintaining Quality Systems and to ensure that all operations are fully in compliance with current international standards for cGMP. The individual is responsible for, but is not limited to:Managing the product stability programmeInvestigating out-of-specification (OOS) reports & deviationsAct as lead auditor in third party vendor audits, to include: GMP contract manufacturing, analytical testing, and storage locations when required to ensure compliance with Jazz requirements and country specific regulations.Monitor the operations at the Contract Manufacturer. Perform batch review, review product complaints, deviations, change controls and product related investigations.Be a key member of company audit team during regulatory or customer audits.Support the product complaints systemOperate the CAPA systemDevelop and write SOPs & controlled documents.Implement and improve Quality Systems to realize the highest quality standards attainable for all activities conducted by the company.Report Quality MetricsReview and approval of product artworkAssisting in preparation of Annual Product ReviewsBuild authentic relationships and participate in business meetings, as required, with suppliers and contract manufacturers and maintain all product-related, Quality Technical Agreements (QTA’s).Other Responsibilities:Work directly with other key Company departments to ensure compliance and productive working relationships.Work closely with other members of Technical Operations group to ensure delivery of key project objectives and timelinesContribute to management of the supplier approval programme and to maintenance of the external audit schedule.Assist with troubleshooting quality issues at Partner’s or vendor’s site or associated with technology transfer, when required.Maintain appropriate Quality Technical Agreements with all GxP vendorsSupporting regulatory submissionsProfessional Competencies:Bachelor’s degree in chemistry, biology or a related disciplineExperience working in finished product pharmaceutical / biologics, including analytical chemistry, quality assurance, quality control, development, and /or manufacturing areasExperience with third party vendor auditing, out of spec investigations, change controlThorough understanding of quality systems and cGMP’sInterpersonal skills and professional skills to interact at all levels including senior executives, contractors, and colleaguesExperience working with contract manufacturingExperience interfacing with regulatory bodies or working on regulatory submissions

Locations

Dublin Ireland

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