Quality Systems Technician

2 weeks ago

Dublin, Dublin City, Ireland Grifols Shared Services North America, Inc Full time
Grifols Shared Services North America, Inc Quality Systems Technician in Dublin, Ireland

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.

The Quality Systems Technician will be responsible for management of Documentation Compliance Manager (DCM) and archiving in relation to QMS systems.

Responsibilities include:

  1. Conducting Internal audits
  2. Managing Change Control system
  3. Managing CAPA system
  4. Handling Supplier complaints
  5. Overseeing vendor/service provider qualification
  6. Other activities related to QMS as assigned by the Technical Director/Quality Systems and Compliance Manager/Quality Systems Supervisor

What your responsibilities will be:

  1. Management of Documentation Compliance Manager (DCM) system
  2. Provide Reports to site in relation to Quality Management System (QMS) Documentation System as required
  3. Management of Documentation Archive for QMS documentation
  4. Authoring/reviewing of Standard Operating Procedures (SOPs) in relation to GWWO QMS
  5. Communicate with cross-functional departments
  6. Communication with the manufacturing sites of Grifols in relation to QMS activities where appropriate
  7. Management and coordination of Internal audit system in GWWO
  8. Management and coordination of Change Control system in GWWO
  9. Management and coordination of CAPAs in GWWO
  10. Management of the Supplier Qualification/Performance assessment process
  11. Management of Supplier complaints
  12. Providing GMP trainings for personnel working in aseptic and non-aseptic environment
  13. Trending and reporting of GWWO Quality metrics
  14. Managing of Annual Product Reports
  15. Contribution to the continuous improvement of the Quality Management System
  16. Management of GMP introductory and annual refresher training for all GWWO employees
  17. Any other training in relation to Compliance, as required
  18. Provide support to corporate and health authorities' site audits and response to audits' findings
  19. Provide active support to ensure GWWO's audit readiness and compliance with regulations and Health Authorities' expectations

What you will bring:

  1. Competence in Microsoft packages specifically Word, Excel and PowerPoint
  2. Ability to work proactively on own initiative
  3. Ability to work independently
  4. Excellent technical writing and analytical skills
  5. Good organizational and time management skills
  6. Flexibility
  7. Results-oriented
  8. Minimum of 1 year experience in Quality Systems/Document Control role in pharma industry
  9. Knowledge and understanding of compliance, EU, and FDA GMP guidelines
  10. Previous experience in managing/coordinating Change Controls, CAPAs, Deviations, Supplier Qualification, Supplier Complaints
  11. Degree in a science, pharmacy or related discipline
  12. Previous experience and contribution in site's regulatory audits
  13. Experience in working in aseptic area and understanding of Annex 1 requirements
  14. Experience of working in a team environment and participating in Project teams

What we offer:

It's a brilliant opportunity for someone with the right talents. Grifols understands you want a challenging and rewarding career in a critical function such as Corporate Communications. We'll help you grow professionally.

Our Benefits Include:

  1. Highly competitive salary
  2. Group pension scheme - Contribution rates are (1.5% / 3%/ 5%/ 7%) and the company will match
  3. Private Medical Insurance for the employee
  4. Ongoing opportunities for career development in a rapidly expanding work environment
  5. Succession planning and internal promotions
  6. Wellness activities - Social activities e.g. Golf, Padel, Summer Events

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. We encourage everyone who meets the qualifications to apply – we're excited to hear from you.

#LI-FD1

Learn more about Grifols (http://www.grifols.com/es/web/international/home)

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