QA Manufacturing 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:
- Provide QA oversight for GMP manufacturing operations, ensuring compliance with cGxP, EU Annex 1, FDA, and internal quality standards.
- Support batch release readiness through timely review and completion of quality documentation.Conduct shop floor presence activities, including GEMBA walks and manufacturing observations, to maintain GMP compliance and inspection readiness.
- Review, approve, and author GMP documentation, including SOPs, batch records, risk assessments, and training records.
- Support deviations, investigations, CAPAs, change controls, and continuous improvement initiatives.
- Act as the primary QA contact for manufacturing operations, providing guidance on quality, compliance, and aseptic processing activities.
- Drive quality culture by coaching and supporting Manufacturing, Maintenance, and Quality teams on GMP, contamination control, and aseptic best practices.
- Participate in risk assessments, validation activities, media fills, smoke studies, and contamination control initiatives.
- Support internal and external inspections and maintain inspection-ready documentation.
- Contribute to operational improvement and project activities to enhance quality, compliance, and manufacturing performance.
- Minimum Bachelors degree in a scientific discipline.
- Minimum 3 years’ experience in aseptic manufacturing within a Quality or Manufacturing capacity in a GMP-regulated environment, preferably utilizing RABS technology (Grade A & B) is a requirement.
- Working experience with QMS processes, both paper-based and electronic systems (e.g., Batch Records, LIMS, Veeva Vault, Trackwise, etc.)
- Understanding of GMP regulation and guidance, notably Annex 1 ‘Sterile Manufacture’ and FDA Aseptic Guide.
- Working experience with deviations, Investigations, and CAPAs.
- Strong organisational and coordination ability
- High attention to detail and accuracy under pressure
- Ability to multitask and manage shifting priorities effectively
- Proactive and solution-oriented mindset
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