Principal Specialist - QA Engineering

Key responsibilities and minimum requirements according to the role: • Provide QA oversight and collaborate with cross-functional teams in planning maintenance, qualification, and validation activities for facilities, utilities, equipment, and computer systems (CSV). • Serve as a Quality representative and a subject matter expert (SME) in selection, design and build of new technologies and new facilities within Alvotech. • Support and provide QA oversight with review and approval of qualification documents for facility, utility, equipment and computerized systems as applicable. • Contribute to investigations into discrepancies arising during qualification / validation activities and subsequent approval of appropriate corrective actions. • Review of planned and unplanned work orders for maintenance, preventive maintenance, calibrations and other Engineering related activities. • Reviews and approve change controls, deviations , CAPAs , effectiveness checks for facilities, utilities, and equipment, computer systems. • Stay current on applicable external requirements and industry standards and drive continuous improvement on Engineering and CSV processes and tools. • Advice on quality matters, and assistance for closing compliance gaps found in audits and inspections. • Escalation of any data integrity or critical quality issues to the supervisor and Quality Management of Alvotech • Responsible for ensuring all facilities, utilities, equipment , computer systems are appropriately validated and qualification in line with current EU and US legislation for parenteral/biologics. Minimum education and experience required for the role: • A bachelor’s degree within relevant area, or other relevant business experience • Minimum 5 years of experience within the Pharmaceutical or Medical Device Industry (preferably in parenteral/biologics formulations). • Experience working with regulatory requirements in GxP required (Preferably FDA and EU regulations). • Good understanding of GAMP 5 guide required. • Knowledge of and experience with validation and qualification specifically within facility, utility, and equipment/computer systems.