Dublin QA Manufacturing Specialist

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. Position Summary: The QA Manufacturing Specialist - Shop Floor is responsible for providing quality oversight and guidance for GMP manufacturing operations within the Albumin production facility. The successful candidate will partner closely with Manufacturing, Maintenance, Automation, and Quality teams to ensure the safe and compliant production of Albumin products. Key responsibilities include supporting day-to-day manufacturing operations, reviewing and resolving quality issues, facilitating product release activities, and promoting a strong culture of quality and compliance. As a subject matter expert in GMP compliance, the QA Specialist will provide coaching and guidance to operational teams while ensuring adherence to industry regulations and aseptic manufacturing standards. A solid understanding of sterile manufacturing requirements, including EU GMP Annex 1 and aseptic processing principles within Grade A-D cleanroom environments, is essential for success in this role. What You Will Do: 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. What You Will Bring: 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. #LI-AM1 Location: Grange Castle International Business Park, Grange, Co. Dublin, D22 K2R3 Learn more about Grifols Apply now » Find similar jobs: EMEA, all_jobs, ALLJOBS/, ALLJOBS Grifols LinkedIn Privacy Notice Cookies Policy Cookies Settings Additional Candidate Resources © 2026 Grifols, S.A. All rights reserved worldwide Cookie Consent Manager When you visit any website, it may store or retrieve information on your browser, mostly in the form of cookies. Because we respect your right to privacy, you can choose not to allow some types of cookies. However, blocking some types of cookies may impact your experience of the site and the services we are able to offer. Strictly Necessary Cookies These cookies are necessary for the website to function and cannot be switched off in our systems. They are usually only set in response to actions made by you which amount to a request for services, such as setting your privacy preferences, logging in or filling in forms. You can set your browser to block or alert you about these cookies, but some parts of the site will not then work. Strictly Necessary Cookies Strictly Necessary Cookies Provider Description Enabled SAP / Grifols We use the following session cookies, which are all required to enable the website to function: SAP as service provider: "JSESSIONID" is placed on the visitor's device during the session so the server can identify the visitor. Grifols: "JSESSIONID" is placed on the visitor's device during the session so the server can identify the visitor. "COOKIE_SUPPORT" is used to store the browser's ability to manage cookies. "TS01xxxxxxxx" is used to manage the web session. "GUEST_LANGUAGE_ID" is used to remember the user's linguistic preferences. Cookies from provider SAP/Grifols are required and cannot be turned off Targeting Cookies These cookies may be set through our site by our advertising partners. they may be used by those companies to build a profile of your interests and show you relevant adverts on other sites. They do not store personal information that directly identify you but are based on uniquely identifying your browser and internet device. Consent to all Targeting Cookies Targeting Cookies Provider Description Enabled Google Tag Manager We use the following cookies: "cc_ut" is used to collect data for advertising purposes. Consent to cookies from provider GoogleTagManager