QA On the Floor / Gæðaeftirlit á framleiðslugólfi at Alvotech

Description

<div>Við leitum að lausnamiðuðum og nákvæmum QA On‑the‑Floor (QA OTF) sérfræðingi til að veita rauntíma gæðaeftirlit í framleiðslu á virku efni (DSM) og lyfjavöru (DPM). Hlutverkið felst í að tryggja að farið sé eftir GMP/GDP/ALCOA kröfum með virkri viðveru á gólfi, yfirferð skjala og náinni samvinnu við framleiðsluteymi.(English)We are looking for a hands‑on and detail‑oriented QA On‑the‑Floor (QA OTF) specialist to provide real‑time quality oversight in drug substance (DSM) and drug product (DPM) manufacturing areas. The role focuses on ensuring GMP/GDP/ALCOA compliance through active shop‑floor presence, documentation review, and close collaboration with manufacturing teams.</div><div>Scope & Responsibilities<ul><li>Act as the QA contact for DSM/DPM during rotational shifts and support batch or facility issues.</li><li>Ensure compliance with GMP, GDP, ALCOA; guide operators and address deviations or corrections as needed.</li><li>Perform routine shop‑floor monitoring and document observations per SOP.</li><li>Review alarm logs (BRIEM) and critical MLOGs; escalate observations when required.</li><li>Approve IPT/IPC failure assessments.</li><li>Verify area readiness, line clearance, and area release for DSM/DPM.</li><li>Support media fills, cell bank issuance, and AQL sampling.</li><li>Manage reconciliation and archiving of MLOGs and QA‑OTF forms.</li><li>Handle visual inspection kits and conduct area release checks pre/post shutdown.</li><li>Contribute to inspection readiness, audits, and updates to QA‑OTF SOPs.</li><li>Train new QA team members when needed.</li></ul></div><div>Minimum Requirements<ul><li>Bachelor’s degree in Life Sciences, Pharmacy, or related field.</li><li>2+ years of experience in GMP‑regulated pharmaceutical or biotech manufacturing.</li><li>Solid understanding of quality systems, documentation standards, and regulatory expectations.</li><li>Strong communication skills and a collaborative approach.</li><li>Ability to work rotational shifts in a fast‑paced production environment.</li></ul></div>What we offer:<ul><li>An inspiring challenge to work with great co-workers on ambitious projects that change people's lives.</li><li>The chance to be a part of a global and fast-growing company.</li><li>An international work culture that encourages diversity, collaboration and inclusion.</li><li>Positive, flexible, and innovative work environment.</li><li>Support for personal growth and internal career development.</li><li>Company social events and milestone celebrations.</li><li>Excellent in-house canteen and coffee house.</li><li>Exercise and wellbeing support for full-time employees.</li><li>On-site shower facility.</li><li>Transportation grant towards eco-friendly modes of travel for full-time employees.</li><li>Internet at home for full-time employees.</li></ul>Why AlvotechAt 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. 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.

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QA On the Floor / Gæðaeftirlit á framleiðslugólfi

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Alvotech

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