QA Manufacturing Specialist

<p> </p> <p>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.</p> <p>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.</p> <p> </p> <p>The role of the <b>QA Manufacturing Specialist</b> is to complete and support activities within the Quality Department relating to GMP Compliance and to provide Quality support for the aseptic manufacturing operations in Grifols Worldwide Operations Ltd (GWWO). <br/> <br/>  </p> <p><b>KEY RESPONSIBILITIES</b></p> <p><u>General:</u></p> <ul> <li>Act as a representative for the Quality team in the absence of the quality supervisor/manager</li> <li>Communication:</li> <li>Daily briefing on Quality batch review/approval</li> <li>Provide quality performance information as required</li> <li>Ensure regular Quality interaction with other Departments </li> </ul> <p>    <br/> <u>Quality Assurance Activities:</u></p> <ul> <li>Support method transfer plans, qualification of sampling plans for water systems, raw materials, environmental monitoring, in- process and FP testing</li> <li>Assist and participate in qualification of cleaning processes, clean rooms and sterilisation processes, aseptic gowning and other qualification processes where required. Review and approval of qualification pack.</li> <li>Support the Aseptic Process Simulation and Batch Manufacture activities including observation of critical interventions as required for batch review.</li> <li>Qualify in gowning for entry to Grade A/B area.</li> <li>Review of Batch Records. </li> <li>Lead and/participate in technical deviations, investigations, CAPA and change controls and provide Quality support to the manufacturing area.</li> <li>Maintain a high level of technical writing expertise and stay current with regulatory trends.</li> <li>Involve in customer complaint investigation if required.</li> </ul> <p> <br/> <u><b>PERSON SPECIFICATION</b></u></p> <ul> <li>Excellent communication skills</li> <li>Strong technical writing skills. </li> <li>Competence in Microsoft packages specifically word, excel and PowerPoint</li> <li>Good organizational skills</li> <li>Flexibility</li> <li>Results orientated</li> <li>Ability to make decisions</li> <li>Ability to handle multiple projects and deadlines</li> </ul> <p> </p> <p><u><b>Our Benefits Include:</b></u></p> <ul> <li>Highly competitive salary</li> <li>Group pension scheme - Contribution rates are 5% employer and 5% employee</li> <li>Private Medical Insurance for the employee</li> <li>Ongoing opportunities for career development in a rapidly expanding work environment</li> <li>Succession planning and internal promotions</li> <li>Education allowance</li> <li>Wellness activities - Social activities eg. Padel, Summer Events</li> </ul> <p> <br/> 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</p> <p> <br/>  </p> <p>#LI-FD1</p> <p></p> <p><b>Location: <span>EMEA : Ireland : Dublin || EMEA : Czech Republic : Home Office || EMEA : Czech Republic : Praha || EMEA : Egypt : Egypt || EMEA : Egypt : Home Office || EMEA : France : Home Office || EMEA : France : Meyreuil || EMEA : France : Paris || EMEA : Germany : Augsburg || EMEA : Germany : Bayreuth || EMEA : Germany : Berlin-Charlottenburg || EMEA : Germany : Berlin-Hellersdorf || EMEA : Germany : Berlin-Marzahn || EMEA : Germany : Berlin-Prenzlauer-Berg || EMEA : Germany : Berlin-Tegel || EMEA : Germany : Berlin-Wedding || EMEA : Germany : Bonn || EMEA : Germany : Brandenburg a. d. Havel || EMEA : Germany : Chemnitz || EMEA : Germany : Dortmund || EMEA : Germany : Dresden-Fetscherplatz || EMEA : Germany : Dresden-Kaditz || EMEA : Germany : Dresden-World Trade Center || EMEA : Germany : Erfurt || EMEA : Germany : Essen || EMEA : Germany : Frankfurt (Oder) || EMEA : Germany : Frankfurt am Main, Niederrad || EMEA : Germany : Freiberg || EMEA : Germany : Fürth || EMEA : Germany : Gera || EMEA : Germany : Gotha || EMEA : Germany : Grimma || EMEA : Germany : Görlitz || EMEA : Germany : Halle (Saale) || EMEA : Germany : Hamm || EMEA : Germany : Home Office || EMEA : Germany : Ingolstadt || EMEA : Germany : Jena || EMEA : Germany : Langen-Hessen || EMEA : Germany : Leipzig Zentrum Südost || EMEA : Germany : Leipzig-Connewitz || EMEA : Germany : Leipzig-Gohlis || EMEA : Germany : Leipzig-Markt || EMEA : Germany : Lübeck || EMEA : Germany : München || EMEA : Germany : Nürnbe