QA Senior Specialist

<div><p>Við leitum að hæfum og nákvæmum reyndum QA sérfræðingi til að styðja við gæðamál DSM og DPM. Í þessu hlutverki munt þú veita sérfræðiráðgjöf í gæðamálum, tryggja að farið sé eftir GMP kröfum og leggja þitt af mörkum til stöðugra umbóta í framleiðslusvæðum fyrirtækisins.</p><p></p><p><b>(English)</b></p><p></p><p>We are looking for a skilled and detail‑oriented QA Senior Specialist to support QA Operations for DSM and DPM. In this role, you will provide expert QA guidance, ensure compliance with GMP requirements, and contribute to continuous improvement across production areas.</p></div><div><p></p><p><b>Scope and Key Responsibilities</b></p><ul><li><p>Act as the QA contact for DSM and DPM.</p></li><li><p>Provide QA support and expertise for daily operations.</p></li><li><p>Support and approve investigations for Deviations, Risk Assessments, OOS results, and related CAPAs.</p></li><li><p>Review and approve Change Controls.</p></li><li><p>Participate in the resolution of CAPAs linked to inspection findings.</p></li><li><p>Review and approve batch records, associated documentation, product specifications, and master batch records.</p></li><li><p>Review and approve SOPs and other documents within the area of responsibility.</p></li><li><p>Contribute to inspection readiness and support inspection activities.</p></li><li><p>Train new QA Operations team members and support cross‑training as needed.</p></li><li><p>Participate in continuous improvement of the Quality Management System.</p></li></ul><div><h3></h3><h3><b>Minimum Requirements</b></h3><ul><li><p>Relevant university degree in life sciences, pharmaceutical sciences, or a related field.</p></li><li><p>Solid experience working in a GMP‑regulated environment.</p></li><li><p>Strong understanding of QA processes (deviations, CAPAs, change control, documentation review).</p></li><li><p>Excellent communication, collaboration, and problem‑solving skills.</p></li><li><p>High attention to detail and strong ability to work independently.</p></li><li><p>Strong organizational skills and ability to work in a fast‑paced environment.</p></li></ul></div></div><p></p><p><b><span style="font-size:inherit">What we offer:</span></b></p><ul><li><p><span style="font-size:inherit">An inspiring challenge to work with great co-workers on ambitious projects that change people&#39;s lives.</span></p></li><li><p><span style="font-size:inherit">The chance to be a part of a global and fast-growing company.</span></p></li><li><p><span style="font-size:inherit">An international work culture that encourages diversity, collaboration and inclusion.</span></p></li><li><p><span style="font-size:inherit">Positive, flexible, and innovative work environment.</span></p></li><li><p><span style="font-size:inherit">Support for personal growth and internal career development.</span></p></li><li><p><span style="font-size:inherit">Company social events and milestone celebrations.</span></p></li><li><p><span style="font-size:inherit">Excellent in-house canteen and coffee house.</span></p></li><li><p><span style="font-size:inherit">Exercise and wellbeing support for full-time employees.</span></p></li><li><p><span style="font-size:inherit">On-site shower facility.</span></p></li><li><p><span style="font-size:inherit">Transportation grant towards eco-friendly modes of travel for full-time employees.</span></p></li><li><p><span style="font-size:inherit">Internet at home for full-time employees.</span></p></li></ul><p></p><p></p><p><b><span style="font-size:14px">Why Alvotech</span></b></p><p><span style="font-size:14px">At Alvotech, we are passionate about improving lives by increasing access to affordable biologics. We’re purpose-driven and committed to fostering an inclusive and diverse working environment that encourages curiosity, ingenuity and simplicity. We want our employees to feel inspired in their careers, challenged by interesting and meaningful work and empowered to succeed in an agile environment.<br /> </span></p><p><span style="font-size:14px">True to our Icelandic roots, we also believe that integrity, gender equality, and fairness are foundational. We strive to bring together the brightest minds regardless of backgrounds and beliefs, to deliver to our partners and patients around the world. Let’s create a healthier world together, through affordable biologic medicines.</span></p>