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Quality Management Systems Coordinator

3 weeks ago

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

The Quality Systems Specialist will play a key role in ensuring the effective management of our Quality Management System (QMS). The ideal candidate will have extensive knowledge and understanding of compliance, EU and FDA GMP guidelines, and minimum of 2 years' experience in Quality Systems/Document Control role. They will also possess a degree in a science, pharmacy or related discipline, and previous experience and contribution in site's regulatory audits. Additionally, they should have experience in working in aseptic area and understanding of Annex 1 requirements, as well as competence in Microsoft packages specifically Word, Excel and PowerPoint.

Responsibilities of the role include:
  1. Management of Documentation Compliance Manager (DCM) systemProviding 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 QMS.Communicate with cross functional departmentsCommunication with the manufacturing sites of Grifols in relation to QMS activities where appropriate.Management and coordination of Internal audit system in GWWO.Management and coordination of Change Control system in GWWO.Management and coordination of CAPAs in GWWO.Management of the Supplier Qualification/Performance assessment process.Management of Supplier complaints.Providing GMP trainings for personnel working in aseptic and non-aseptic environment.Trending and reporting of GWWO Quality metrics.Managing of Annual Product Reports.Contribution to the continuous improvement of the Quality Management System.Management of GMP introductory and annual refresher training for all GWWO employees.Any other training in relation to Compliance, as required.Provide support to corporate and health authorities' site audits and response to audits' findings.Provide active support to ensure GWWO's audit readiness and compliance with regulations and Health Authorities' expectations.

What We Offer

We offer a highly competitive salary package, including a group pension scheme, private medical insurance, and ongoing opportunities for career development in a rapidly expanding work environment. We also provide succession planning and internal promotions, as well as wellness activities and social events.