Quality Compliance Specialist

5 days ago

Dublin, Dublin City, Ireland Grifols Shared Services North America, Inc Full time
Grifols Shared Services North America, Inc Quality Compliance Specialist 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.

Reporting to the Quality Systems and Compliance Manager, the Quality Compliance Specialist is responsible for maintaining site compliance of Operations inclusive of, but not limited to, Manufacturing, Quality Systems, Quality Control, Quality Assurance, Facilities, Maintenance, Materials handling, and Validation in accordance with regulatory requirements and site expectations.

What your responsibilities will be:

  1. Participating as an SME in self-inspection, Health Authority, Corporate or Customer inspections, including audit readiness activities.
  2. Collaborate with relevant departments to ensure compliance with corporate policies, GMP and regulatory requirements.
  3. Support the evaluation of the regulations and industry trends to identify opportunities and to strengthen the GxP training program.
  4. Support the site Quality Council program.
  5. Participate in the global working groups to ensure best practices are implemented on site.
  6. Provide reports and collate site metrics as required.
  7. Support the authoring of controlled documents (e.g SOP's, Policies, etc).
  8. Perform reviews of Quality agreements between GWWO and its affiliated sites, customers and suppliers where applicable.
  9. Review of procedures, policies and other instructional documents to ensure compliance to company policy and local and international regulatory requirements.
  10. Identify gaps in systems and develop feasible plans for correction.
  11. Actively participate in continuous improvement initiatives.
  12. Participate in quality risk assessments and management.
  13. Ensure the corrections of findings, risks and recommendations are promptly and thoroughly incorporated into the quality systems.
  14. Participate in investigations of quality system issues and drive CAPA implementation to ensure CAPA findings, risks, recommendations, and outcomes are appropriate and are clearly documented and communicated.
  15. Support quality events to identify, bracket, correct, control, and prevent defects.
  16. Trend, analyze, and report on quality data to improve product and process Quality; develop recommendations based on data analyses.
  17. Implement, coordinate and maintain a dynamic site Data Integrity programme.

All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional tasks and responsibilities.

What you will bring:

  1. Minimum of 3 years' experience in Quality Systems/Quality Assurance environment.
  2. Ability to handle multiple projects and priorities with exceptional organizational time management skills.
  3. Excellent communication skills, both verbal and written.
  4. Competence in Microsoft packages specifically Word, Excel and PowerPoint.
  5. Detail oriented with ability to work in teams and proactively on own initiative.
  6. Excellent technical writing and analytical skills.
  7. Results oriented.
  8. Process improvement and procedure writing expertise.
  9. Experience in audit/inspections.
  10. Flexible, able to adapt quickly to change in a fast-paced environment.

Qualifications / Education Certification:

BSc or MSc in a science, pharmacy or related discipline.

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:

  1. Highly competitive salary.
  2. Group pension scheme - Contribution rates are (1.5% / 3%/ 5%/ 7%) and 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 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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