About this role
Alvotech hf is seeking a QA On the floor specialist. Join Alvotech’s Quality Assurance team and play a key role in supporting manufacturing operations while ensuring compliance with GMP requirements and quality standards. This hands-on position provides real-time QA support to manufacturing teams and contributes to the delivery of high-quality biopharmaceutical products. Please note that this is a rotational shift position, requiring flexibility to support manufacturing operations across designated shifts in a 24/7 production environment. Scope and Responsibilities: - Act as the primary QA contact for DPM and DSM operations during rotational shifts. - Provide QA support for batch-related and facility issues, including deviations and CAPAs. - Perform shop floor monitoring and ensure compliance with GMP, GDP, and ALCOA principles. - Review manufacturing documentation, alarm logs, and failure assessments. - Approve area release, line clearance, and other QA-controlled activities. - Support media fills, cell bank issuance, AQL sampling, and visual inspection activities. - Maintain QA documentation and support inspection readiness and audits. - Contribute to SOP updates and train new QA team members as needed. Job Requirements: - Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, or a related field. - Minimum 2 years of experience in a GMP-regulated pharmaceutical or biotechnology manufacturing environment. - Strong knowledge of GMP, quality systems, documentation practices, GDP, and ALCOA principles. - Experience supporting manufacturing operations and quality oversight activities. - Strong attention to detail and problem-solving skills. - Excellent communication and collaboration abilities. - Ability to work rotational shifts in a fast-paced manufacturing environment. - Proficient in written and spoken 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 well-being 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. Please apply by sending your application with CV to: [email protected] Last application date October 14th, 20206.