Quality Systems Specialist

Job title:

Quality Systems Specialist

Company

Grifols

Job description

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) system
• Provide 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 departments
• Communication 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 Suppler 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
• Other 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 guidelines
• Previous experience in managing/coordinating Change Controls, CAPAs, deviations, supplier qualification, supplier complaints
• Degree in a science, pharmacy or related discipline.
• Previous experience and contribution in site’s regulatory audits
• Experience/certification in auditing
• Experience in working in aseptic area and understanding of Annex 1 requirements
• Experience of working in a team environment and participating in Project teams.
• Excellent communication skills
• Competence in Microsoft packages specifically word, excel and PowerPoint
• Ability to work proactively on own initiative
• Ability to work independently
• Excellent technical writing and analytical skills
• Good organizational and time Management skills
• Flexibility
• Results orientated

What 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 salary
• Group pension scheme – Contribution rates are (1.5% / 3%/ 5%/ 7%) and company will match
• Private Medical Insurance for the employee
• Ongoing opportunities for career development in a rapidly expanding work environment
• Succession planning and internal promotions
• Education allowance
• Wellness 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.
#LI-FD1Location: EMEA : Ireland : Dublin:Grange Castle (Dublin)

Expected salary

Location

Dublin

Job date

Sun, 02 Mar 2025 07:34:09 GMT

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