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Batch record reviewer / Sérfræðingur í yfirferð lotuskráa

Alvotech
3 days ago
Full-time
On-site
Reykjavik Headquarters
Operations
Hefur þú gott auga fyrir smáatriðum og áhuga á gæðamálum í lyfja- og líftækniiðnaði? Við erum að leita að metnaðarfullum Batch Record Reviewer til að tryggja að framleiðsla okkar uppfylli strangar reglugerðarkröfur og hæstu gæðastaðla. (English) Are you detail-oriented and passionate about quality assurance in the pharmaceutical or biotech industry? We are seeking a dedicated Batch Record Reviewer to ensure compliance with regulatory standards and maintain the highest quality in our production processes. Scope & Responsibilities: Review and approve batch records for accuracy and completeness. Ensure compliance with cGMP regulations and internal SOPs. Collaborate with cross-functional teams to resolve discrepancies. Participate in audits and inspections as needed. Qualifications and skills: Bachelor’s degree in a scientific discipline or equivalent experience. Experience in batch record review or quality assurance in a regulated environment is a plus. Strong attention to detail and analytical skills. Excellent communication and teamwork abilities. 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 Alvotech 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. 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. At Alvotech, we are building a global biotechnology company with a clear purpose: to expand access to high-quality, affordable biologic medicines for patients worldwide. Our people are central to that mission. Across our global teams, we bring together expertise in science, manufacturing, quality and commercial operations to shape the future of biosimilars. We offer a dynamic, fast-moving environment where curiosity, initiative and ownership are encouraged. Rooted in Icelandic values and operating on a global stage, we value collaboration, diversity and integrity across everything we do. Our teams work on meaningful challenges, contribute directly to patient impact, and grow alongside the business. Whether you are at the start of your career or looking to take your next step, Alvotech offers the opportunity to do work that matters, in a company driven by purpose and scale. If you do not see a role that matches your experience today, we still welcome general applications from individuals who share our ambition and want to help improve access to biologic medicines worldwide. If you have any technical issues, please contact: hr@alvotech.com