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.
Skills Required
- Bachelor's degree in a relevant area or equivalent relevant business experience
- Minimum 5 years of experience in the pharmaceutical or medical device industry
- Experience with pharmaceutical or medical device products, preferably parenteral or biologics formulations
- Experience with GxP regulatory requirements, preferably FDA and EU regulations
- Good understanding of the GAMP 5 guide
- Experience with validation and qualification of facilities, utilities, equipment, and computerized systems
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What We Do
Alvotech is a global biotechnology company focused exclusively on developing and manufacturing biosimilar medicines. Its mission is to improve patients’ lives by expanding access to affordable biologic treatments worldwide. The company operates as a fully integrated specialty biopharmaceutical business, pursuing high-quality biosimilars and building treatment options that can make important biologic therapies more accessible to patients through its research, development, and production capabilities.
