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Alvotech

Principal Specialist - QA Engineering

Alvotech Reykjavik, Iceland

Biotechnology Research · 501-1,000 employees

Yesterday
qa Senior (5-10 yrs) Full-time Iceland
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About the role

The Principal Specialist provides QA oversight for the qualification and validation of facilities, utilities, equipment, and computer systems. They also serve as a subject matter expert to ensure compliance with GxP, FDA, and EU regulations during engineering and maintenance activities.

What they look for

QA Oversight Validation Qualification CSV GAMP 5 GxP FDA Regulations EU Regulations Biologics Parenteral Formulations Change Control CAPA Data Integrity Compliance Quality Management Engineering

Requirements

Candidates must hold a bachelor's degree and have at least 5 years of experience in the pharmaceutical or medical device industry. Proficiency in GAMP 5, validation processes, and regulatory compliance for biologics is required.

Full description

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.

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