Amgen Information Systems Compliance Specialist in Dun-Laoghaire-Rathdown, Ireland
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.
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.
Support execution of IQ, OQ, PQ's on processes, equipment and systems in conjunction with site suppliers as appropriate.
Leading the team to ensure all aspects of activity within the IS Group adhere to required policies and procedures, including safety and training.
Represent the IS function in preparation and execution of regulatory audits and act as primary IS point of contact for audits.
Drive continuous improvement and process efficiencies in site and network compliance processes and practices, eliminating non-value add work and reducing waste
Oversight and ownership where required of NCs, CAPAs, Periodic Reviews and Quality metrics for the IS team
Be involved in all Validation Cross Functional Teams (CFTs) at the site to ensure adherence to required policies and procedures.
Develop and rollout training relating to IS Compliance for the ADL site.
Attend and participate in Site Inspection Steering Committee (SISC) meetings
Represent ADL in IS compliance network forums.
Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations.
Bachelors in Electrical Engineering, Mechanical Engineering, Computer Science or related engineering discipline with 5-10 years' experience in IS Compliance or Quality Assurance in the biotechnology or pharmaceutical industries.
Understanding of Information Systems, principles of Automation and system architectures.
Experience in cGMP regulated environments and in-depth knowledge regarding FDA cGxP and 21 CFR Part 11 regulations and an understanding software system validation is required and working knowledge of the GAMP software development lifecycle
Experience in change control, non-conformance, corrective and preventative actions, and validation practices.
Ability to ensure compliance with practices, policies, procedures, legal requirements and site objectives and goals.
Ability to operate across functional boundaries, both internal and external.
Ability to work independently and remotely with minimum direct supervision.
Critical thinking skills.
Strong organisational, communication, coordination, and meeting facilitation skills.
Ability to develop and present solutions to management, translating strategic opportunities into tangible pragmatic executable plans.
Independent, self-motivated, organized, able to multi-task in project environments and skilled in communication and collaboration.
Team player, prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making.
Travel at various times may be required to support execution of projects.