Quality Assurance Specialist - Batch Record Reviewer

Rýni á lotuskrám – Gæðasérfræðingur (English below)Áttu auðvelt með að sýna nákvæmni, skipulagshæfni og drifkraft? Þá gætir þú verið lykilaðili í öflugu gæða- og framleiðsluteymi hjá okkur. Alvotech er leiðandi líftæknifyrirtæki sem vinnur að því að gera líftæknilyf aðgengilegri fyrir sjúklinga um allan heim. Helstu verkefni: Yfirfara lotuskrár (framleiðsluskýrslur) í samræmi við GMP reglur og innri verklagsreglur. Tryggja að öll gögn séu rétt og fullnægjandi áður en vörur eru samþykktar til afhendingar.

Samstarf við framleiðslu, gæða- og skjaladeildir til að tryggja samræmi og lausn frávika. Stuðla að stöðugum umbótum innan gæðaferla og taka þátt í innri og ytri úttektum. Hæfniskröfur: Háskólamenntun í lífvísindum, lyfjafræði, efnafræði eða skyldum greinum er æskileg. Reynsla af gæða- eða framleiðslustarfi í lyfjaiðnaði er æskileg. Góð þekking á GMP og skjölunarkerfum er æskileg. Nákvæmni, greiningarhæfni og góður samstarfsvilji. Færni í ensku í ræðu og riti.

(English)Batch Record Reviewer – Quality SpecialistAre you detail-oriented, organized, and driven? You could be a key contributor to our dynamic quality and production team. Alvotech is a leading biopharmaceutical company dedicated to making biologic medicines more accessible to patients worldwide. Your Role at Alvotech: Review and approve batch manufacturing records to ensure accuracy, completeness, and compliance with GMP and internal standards. Coordinate with production, quality assurance, and documentation teams to resolve discrepancies and ensure timely release of product. Document record status and contribute to continuous improvement of batch review processes.

Support audit readiness by maintaining robust documentation practices and participating in internal and external inspections. Qualifications: Bachelor's degree in life sciences, pharmaceutical sciences, chemistry, or related field is preferred. Experience in a GMP-regulated pharmaceutical or biotech environment is preferred. Thorough understanding of Good Manufacturing Practices and documentation systems is preferred. High level of accuracy, accountability, and ability to work independently within deadlinesStrong written and verbal communication skills in English. _________________________________________________________________________________________________________What we offer: An inspiring challenge to work with great co-workers on ambitious projects that change people's lives. The chance to be a part of a global and fast-growing company.

An international work culture that encourages diversity, collaboration and inclusion. Positive, flexible, and innovative work environment. Support for personal growth and internal career development. Company social events and milestone celebrations. Excellent in-house canteen and coffee house. Exercise and wellbeing support for full-time employees. On-site shower facility. Transportation grant towards eco-friendly modes of travel for full-time employees. Internet at home for full-time employees. 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.