Principal Specialist - QA Engineering

Key responsibilities

• 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.