Senior QA Specialist Material & Supplier

<p> </p><p></p><p><span><span>Today,  Lonza is a global leader in life sciences </span><span>operating</span><span> across three continents. While we work in science,<span> </span></span><span>there’s</span><span><span> </span>no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And<span> </span></span><span>that’s</span><span><span> </span>the kind of work we want to be part of.</span><span> </span></span><span> </span></p><p></p><p><span><span>Senior QA</span><span> Specialist </span><span>Material &amp; Supplier </span><span>interacts directly with Lonza’s internal and external </span><span>stakeholders</span><span> </span><span>to provide Quality oversight of the material</span><span> </span><span>and supplier management process on site.</span></span><span> </span></p><p><span><span>H</span><span>e/she </span></span><span><span>ensure</span><span>s</span><span> compliance with</span><span> </span><span>Good Manufacturing Practices</span><span> </span><span>(</span><span>GMP</span><span>)</span><span> regulations for </span><span>implementation of </span><span>raw materials </span><span>and services </span><span>used in</span><span> manufacturing</span><span> and supporting areas</span><span>,</span></span><span><span> </span><span>reviews and approves documents</span><span> </span><span>required </span><span>for</span><span> material assessment and setup, ensures supplier/service provider qualification, and provides compliance knowledge to support r</span><span>esolution of </span><span>material </span><span>release issues and other </span><span>relevant</span><span> </span><span>Q</span><span>uality events</span><span>.</span></span><span> </span></p><p><span><span>As an established Subject Matter Expert (SME), h</span><span>e/she</span><span> provide</span><span>s</span><span> resolution to escalated issues within their area of responsibility and help</span><span>s</span><span> define the strategy for improvements efforts. </span></span></p><p></p><p></p><p><b>Key responsibilities:</b></p><ul><li><p>Provide Quality oversight required to on-board materials on site:</p><ul><li><p>Review and approve raw material lists and material assessments, including relevant supply chain information.</p></li><li><p>Review and approve material specifications.</p></li><li><p>Review and approve material setup in SAP.</p></li><li><p>Participate in cross-functional meetings and actively contribute to facilitate material setup process.</p></li></ul></li></ul><ul><li><p>Provide Quality oversight of the site supplier/service provider qualification:</p><ul><li><p>Identify correct classification of materials, services, and tier required for suppliers/service providers qualification.</p></li><li><p>Review and approve SSPAR.</p></li><li><p>Initiate and manage supplier qualification process.</p></li><li><p>Perform supplier qualification and/or closely work with Global Lonza supplier qualification functions in order to facilitate supplier qualification process.</p></li><li><p>Facilitate supplier complaints management.</p></li><li><p>Facilitate vendor change notifications management.</p></li></ul></li><li><p>Provide QA support, review and approval for all relevant Quality events (Deviation, Change Control, and CAPA).</p></li><li><p>Update and revise relevant SOPs required to ensure compliance in area of expertise.</p></li><li><p>Contribute to continuous improvement for topics related to material assessments, setup and supplier/service provider qualification process.</p></li><li><p>Keep up to date with compliance and regulation guidelines within the industry, and support day-to-day compliance activities in accordance with approved procedures and policies on site.</p></li><li><p>He/she requires little direction and coaching for day-to-day activities, and is expected to be SME to the associated workflows.</p></li></ul><p></p><p></p><p><b>Key requirements:</b></p><p></p><ul><li><p>Bachelor B.Sc. (Master is possible as well)</p></li><li><p>Related experience 2-7 years</p></li><li><p>Flexibility, work must be finished. </p></li><li><p>Planning can change quickly, dynamical environment.</p></li><li><p>English language proficiency</p></li><li><p>Documentation GDP (GMP).</p></li><li><p>QMS knowledge</p></li><li><p>SAP knowledge, subsystem use</p></li></ul><p></p><p><span><span>Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How<span> </span></span></span><span><span>we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.</span><span> </span></span><span> </sp