Quality Systems Specialist

McDermott Laboratories Limited<p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:left">At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.<br /><br />Viatris empowers people worldwide to live healthier at every stage of life.<br /><br />We do so via:<span>  </span><br /><br />Access – Providing high quality trusted medicines regardless of geography or circumstance;<br />Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and<span>  </span><br />Partnership – Leveraging our collective expertise to connect people to products and services.<span>  </span><br /> </p><p>Every day, we rise to the challenge to make a difference and here’s how the Quality Systems Specialist role will make an impact:</p><p></p><p>Key responsibilities for this role include:</p><ul><li><p>Develop and implement site Quality Systems to support the manufacture and release of Combination products, including SOPs, document control, change control, investigations, CAPA, internal auditing, Vendor qualification &amp; management, material and batch disposition, complaints and annual product review.</p></li><li><p>Provide QA support to site to ensure Inspection Readiness.</p></li><li><p>Collaborate with key stakeholders including Engineering, Validation, Manufacturing, Regulatory and Global Quality.</p></li><li><p>Support operation of the site Training system, including preparing and presenting relevant training material, as required.</p></li><li><p>Regulatory Compliance; support Dublin Respiratory reviews and generation of supporting documents including API Declaration, Approved Product List, Approved Oversight List.</p></li><li><p>Keep abreast of regulatory initiatives and new guidance/requirements.</p></li><li><p>Ensure compliance with appropriate regulatory guidance documents, while driving improvements in product and process quality.</p></li><li><p>Support the implementation of the Continuous Improvement program by identifying, leading and implementing improvements.</p></li><li><p>Comply with company and Legislative Environment, Health and Safety Requirements.</p></li><li><p>Support and execute any other duties as assigned.</p></li></ul><p></p><p>The minimum qualifications for this role are:</p><ul><li><p>Educated to degree level with 3&#43; years industry experience.</p></li><li><p>Working knowledge of EU &amp; US regulatory requirements.</p></li><li><p>Experience in designing and implementing quality systems and/or a start-up an advantage.</p></li><li><p>Experience in or knowledge of inhalation dosage forms an advantage.</p></li><li><p>High proficiency in Microsoft Word/Excel/PowerPoint/MS Project etc.</p></li><li><p>Proficiency in electronic systems/databases such as documentation, Trackwise, SAP etc.</p></li><li><p>Good team working and strong communication skills across functions and organization.</p></li><li><p>An ability to work flexibly in a changing environment. Good attention to detail and priority management essential.</p></li><li><p>Flexibility to learn new skills and take on new tasks and responsibilities.</p></li><li><p>The ability to work under pressure to demanding schedules is important, as is the ability to work on one’s own initiative.</p></li></ul><p></p><p>At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.</p><p style="text-align:inherit"></p><p style="text-align:left">A<span><span>t Viatris, we offer<span> </span></span></span><span><span>competitive<span> </span></span></span><span><span>salar</span></span><span><span>ies</span></span><span><span>, benefits</span></span><span><span><span> </span>and</span></span><span><span><span> </span></span></span><span><span>an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.</span></span><span><span> </span></span></p><p style="text-align:inherit"></p><p style="text-align:left"><span>Viatris is an Equal Opportunity Employer. </span></p><p style="text-align:inherit"></p>