Principal Specialist - QA Engineering

Alvotech hf is seeking a Principal Specialist - QA EngineeringWork location - Sæmundargata 15-19, Reykjavik. The position is 100%. 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 continuousimprovement on engineering and CSV processes and tools.• Advice on quality matters, and assistance for closing compliance gaps found in audits andAt the end of the day, the Sen• 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.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...

Summary and match are AI-generated; verify details on the original posting.

Listed via EURES. All sources