About this role
Scope and Responsibilities:
• Management and oversight of individual analytical method transfers for QC, including protocol/report/gap analysis generation and implementation plans, review and approval workflows between the receiving and transferring unit.
• Participate in preparations for regulatory submissions, inspections, and responses to health authorities and/or partners for QC related activities.
• Responsible for ensuring timely completion of individual projects and assisting with establishing and maintaining departmental metrics.
• Independence in assignments and take part in small to medium departmental/cross-functional projects.
• Routinely leads projects internally and with external stakeholders
• Expert knowledge within the field of expertise such as analytical methods, techniques and equipment as well as relevant procedural/process knowledge.
• Ability to discuss challenges and communicate business critical information to supervisor or other relevant stakeholders. Specifics of the role:
• Execution of day-to-day activities within the QC department relating to Analytical Method Transfer, Partner requests, CMO requests and Health authority related activities.
• Ensuring timely completion and support to Health Authority related activities, Partner requests and Analytical Method Transfers.
• Performs both routine tasks within procedures, processes and non-routine tasks such as identifying and/or support/lead change controls, document updates, and CAPAs.
• Management of individual Analytical Method Technology transfer/validation documentation.
• Identifying required document changes and updating of quality documentation.
• Provide technical training and support to the team as needed.
• Be aware of and comply with Alvotech’s current EHS policies. Job requirements:
• Education: Minimum B.S in a technical discipline, (e.g., pharmacy, biotechnology, biochemistry, or a related field)
• Experience: 5+ years of experience in the pharmaceutical or biopharmaceutical industry. • Experience in quality management system, analytical method transfers, and working cross functionally with excellent communicational skills. • Good conceptual, problem-solving, and organizational skills – must be detail-oriented, well-organized, and able to work independently and in teams. • Fluent command of the English language, both written and verbal. 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.