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Quality Systems Specialist 12 Month Contract Location: Dublin, IE
Contract Type: Regular Full-Time
Area: Quality
Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.
At Grifols, we believe that diversity adds value to our business, our teams, and our culture. We are committed to equal employment opportunities that foster an inclusive environment.
POSITION SUMMARY: Reporting to the Quality Systems Supervisor the Quality Systems Specialist is responsible for management of Documentation Compliance Manager (DCM) and archiving in relation to QMS systems.
Responsibilities include managing and coordinating the Internal audit system in GWWO, managing Change Control system, CAPA system, Supplier complaints, the process of vendor/service provider qualification and other activities related to QMS.
This is a 12 Month Fixed Term Maternity Contract KEY RESPONSIBILITIES Management of Documentation Compliance Manager (DCM) systemProvide Reports to site in relation to Quality Management System (QMS) Documentation System as required.Management of Documentation Archive for QMS documentation.Authoring/reviewing of Standard Operating Procedures (SOP's) in relation to GWWO QMSCommunicate with cross functional departmentsManagement and coordination of Internal audit system in GWWOManagement and coordination of Change Control system in GWWOManagement and coordination of CAPAs in GWWOManagement of the Suppler Qualification/Performance assessment processManagement of Supplier complaintsTrending and reporting of GWWO Quality metricsManaging of Annual Product ReportsContribution to the continuous improvement of the Quality Management System PERSON SPECIFICATION Essential/Desirable/Knowledge & Skills Minimum of 2 years' experience in Quality Systems/Document Control role.Extensive knowledge and understanding of compliance, EU and FDA GMP guidelinesPrevious experience and contribution in site's regulatory auditsExperience in working in aseptic area and understanding of Annex 1 requirementsExperience of working in a team environment and participating in Project teams.QualificationsDegree in a science, pharmacy or related discipline. Our Benefits Include: Highly competitive salaryGroup pension scheme - Contribution rates are 5% employer and 5% employeePrivate Medical Insurance for the employeeOngoing opportunities for career development in a rapidly expanding work environmentSuccession planning and internal promotionsWellness activities - Social activities eg. Padel, Summer Events
We understand that self-doubt can hold talented individuals back from applying for opportunities. We encourage everyone who meets the qualifications to apply – we're excited to hear from you
Location: EMEA : Ireland : Dublin : Grange Castle (Dublin)
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