About this role
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.