Senior QA Specialist

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The CompanyA biopharmaceutical company focused on improving patients' lives by identifying, developing, acquiring and commercialising differentiated and accessible medicines that address unmet medical needs.The company has a portfolio of medicines through its orphan and inflammation groups. The company's global headquarters are in Dublin, Ireland. The company also has offices in the US and Europe.The PositionReporting directly to Assoc. Director, Quality Operations, the Senior Quality Assurance Specialist is part of the quality team responsible for ensuring the highest quality standards for the product portfolios by managing the operational quality system elements of deviations, CAPA's, change controls and product complaints. This position is responsible for supporting the maintenance and management of the Pharmaceutical Quality System (PQS), including supporting the oversight of external supplier management to enable effective Quality oversight and compliance to relevant regulatory guidelines. The individual will be responsible for supporting key quality tasks with respect commercial products, development and clinical projects. Responsibilities:Provide support for the development, implementation and maintenance of the Pharmaceutical Quality System and supplier management program.Provide Quality leadership to TOPS teams.Implementation and maintenance of Customer Complaint management.Provide support for management of complaints, deviations, CAPA's and change controls associated with commercial products.Provide operation and maintenance support of quality documentation systemPreparation and delivery of training on Quality related systems, procedures and processes.Support the preparing and compilation of quality metrics for monthly report.Maintain up to date Quality Technical Agreements with all GxP vendors and take on other activities and responsibilities as required due to business needs.Qualifications and Skills Required:Bachelor's degree in chemistry, biology or a related discipline is desirable.Experience working in finished product pharmaceutical / biologics, including analytical chemistry, quality assurance, quality control, development, and /or manufacturing areas.Experience with out of spec investigations and change control.Thorough understanding of quality systems and GMPs.5 Years industry experienceFor immediate consideration please apply with an up to date CV. Not sure yet? Would like more info? Please get in touch with me to discuss further. To find out more about Real please visit www.realstaffing.comReal Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales