Quality Systems Specialist
Dublin, IE
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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. |
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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.
Position Summary:
Reporting to the Quality Systems Supervisor, the Quality Systems Specialist plays a key role in maintaining and continuously improving the site's Quality Management System (QMS). You will be responsible for managing quality system processes including document control, change controls, CAPAs, supplier qualification, supplier complaints, GMP training, and internal audits.
Working closely with cross-functional teams, you will help ensure compliance with EU and FDA GMP requirements while supporting inspection readiness and driving quality excellence across the site.
What You Will Do:
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Manage the site's Quality Management System (QMS) documentation, including the Documentation Compliance Manager (DCM) system and document archiving.
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Prepare and distribute QMS reports, metrics, and compliance trends.
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Author, review, and maintain Standard Operating Procedures (SOPs) and other quality documentation.
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Coordinate and manage Change Controls, CAPAs, supplier qualifications, supplier performance reviews, and supplier complaints.
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Support the planning, coordination, and execution of internal audit programmes.
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Manage Annual Product Reviews and quality system reporting activities.
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Deliver GMP induction and refresher training programmes for employees across the site.
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Provide compliance-related training as required.Collaborate with Quality, Manufacturing, Engineering, Supply Chain, and other departments to support QMS activities.
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Support regulatory inspections and customer audits, including responses to audit observations.
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Drive continuous improvement initiatives to enhance quality system effectiveness and compliance.Help maintain audit readiness and ensure alignment with GMP regulations and health authority expectations.
What You Will Bring:
- Bachelor's degree in Science, Pharmacy, or a related discipline.
- Strong knowledge of EU GMP, FDA regulations, and quality management systems.
- Minimum 2 years' experience in a Quality Systems, Quality Assurance, or Document Control role within a GMP-regulated pharmaceutical environment.
- Experience managing or coordinating Change Controls, CAPAs, deviations, supplier qualification, and supplier complaints.
- Experience supporting regulatory inspections and external audits.
- Excellent written and verbal communication skills.
- Strong technical writing, analytical, and problem-solving abilities.
- Proficiency in Microsoft Office applications, including Word, Excel, and PowerPoint.
- Ability to work independently while collaborating effectively with cross-functional teams.
Our Benefits Include:
- Highly competitive salary
- Group pension scheme - Contribution rates are
- 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
We understand that self-doubt can hold talented individuals back from applying for opportunities. We encourage everyone who meets the qualifications to apply – we're excited to hear from you
We look forward to receiving your application.
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Location: Grange Castle International Business Park, Grange, Co. Dublin, D22 K2R3