Amgen Information Systems Compliance Specialist in Dun-Laoghaire-Rathdown, Ireland

Job Description

Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realise the new science's promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives.

Amgen Dun Laoghaire (ADL) is a 37,000 square metre aseptic drug product operations facility, specialising in secondary manufacturing activities - Formulation, Vial/Syringe Filling, Lyophilisation and Packaging. The ADL site also includes laboratories and cold chain warehouse capabilities. There is a strong culture of continuous improvement and innovation within ADL to strive for solutions that improve health outcomes and dramatically improve people's lives. Amgen is developing the capability to produce all of its medicines in Dun Laoghaire, helping to ensure continuity of supply of our medicines as we expand internationally.

As a member of the Information Systems team, the individual will act as an IS Compliance specialist and will support complex and challenging initiatives across the full breadth of Information Systems.

Key Responsibilities

  • Accountable for the IS Compliance strategy for ADL

  • Accountable for implementation of processes and procedures related to IS compliance

  • Development and ownership of local plans and SOPs as they apply to IS compliance

  • Accountable for implementation of global IS Compliance requirements at ADL and network alignment with global validation processes

  • Development of Validation Plans, Installation Qualifications (IQs), Operational Qualifications (OQs), Process Qualifications (PQs) and associated validation documentation.

  • Day-to-day IS Compliance input related to IS and Automation as required by operations and site projects.

  • Lead compliance activities for the IS Team

  • Prepare, execute, document and report validation protocols in line with GMP's and other regulatory requirements and standards.

  • Assure that all validation test procedures are in line with current corporate and governmental regulations.