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Quality Systems Specialist

1 month ago

Dublin, Dublin City, Ireland Grifols, S.A Full time

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Quality Systems Specialist - 12 Month FTCLocation: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.
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.
Other additional duties may be assigned by the Technical Director/ Quality Systems and Compliance Manager/ Quality Systems Supervisor from time to time if required.
Contribution to the continuous improvement of the Quality Management System is required.
What your responsibilities will be: 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 departmentsCommunication with the manufacturing sites of Grifols in relation to QMS activities where appropriateManagement 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 complaintsProviding GMP trainings for personnel working in aseptic and non-aseptic environmentTrending and reporting of GWWO Quality metricsManaging of Annual Product ReportsContribution to the continuous improvement of the Quality Management SystemManagement of GMP introductory and annual refresher training for all GWWO employeesAny other training in relation to Compliance, as requiredProvide support to corporate and health authorities' site audits and response to audits' findingsProvide active support to ensure GWWO's audit readiness and compliance with regulations and Health Authorities' expectationsOther duties as required by the Technical Director/Quality Systems and Compliance Manager.What you will bring: Minimum of 2 years' experience in Quality Systems/Document Control role.Extensive knowledge and understanding of compliance, EU and FDA GMP guidelinesDegree in a science, pharmacy or related discipline.Previous 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.Competence in Microsoft packages specifically word, excel and PowerPointAbility to work proactively on own initiativeAbility to work independentlyExcellent technical writing and analytical skillsGood organizational and time Management skillsFlexibilityResults orientatedWhat we offer
It is a brilliant opportunity for you, Grifols is fully aware that its employees are one of its major assets.
We are committed to maintaining an atmosphere that encourages all our employees to develop their professional careers in an excellent working environment.
Our Benefits Include: Highly competitive salaryGroup pension scheme - Contribution rates are (1.5% / 3%/ 5%/ 7%) and company will matchPrivate Medical Insurance for the employeeOngoing opportunities for career development in a rapidly expanding work environmentSuccession planning and internal promotionsWellness activities - Social activities eg.
Golf, Padel, Summer Event
If you're interested in joining our company and you have what it takes, then don't hesitate to apply.
We look forward to receiving your application.
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Location: EMEA : Ireland : Dublin : Grange Castle (Dublin)

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