Specialist QA TS

Senior Quality Assurance Professional – QA Technical Support

Amgen is committed to unlocking the potential of biology for patients suffering discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

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 its medicines in Dun Laoghaire, helping to ensure continuity of supply of our medicines as we expand internationally.

ADL provides state of the art working facilities, including Next Generation office areas and on site GYM. In addition ADL provide flexible working conditions, including flex hours and work from home.

The Quality Assurance Technical Support (QA TS) Specialist is a senior position within the QA function which will typically report to a QA Senior Manager and will be required to be a Subject Matter Expert in their assigned area of responsibility.

Key Responsibilities

• Provide overall quality direction and oversight for key functional areas (i.e. Packaging, Validation, Quality Control, Engineering, Automation & Information Systems), ensuring that programs, policies and procedures are robust and in keeping with regulatory and Amgen expectations.
• Quality review and approval of Validation documentation and SOPs to support site validation activities:
  • Review of DS & QRAES documents
  • Review of validation Plans, Protocols, IQ, OQ, PQ and associated validation documents
  • Review of executed validation documents and reports
• Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations
• Provide Quality direction and input at Change Control and Deviation Review Boards and assume QA oversight of change control and Deviation/CAPA records; ensuring scope of record is clear and implementation activities are robust and timely. 
• Perform all activities in compliance with Amgen safety standards and SOPs 

In line with business requirements, these responsibilities may expand or otherwise include additional areas of responsibility which are not described in this specification but are associated with the role 

Preferred Qualifications

• University degree. Science or Engineering related discipline preferred. 
• Relevant experience (7yrs +) working in the pharmaceutical or biotechnology industry as a Subject Matter Expert providing overall quality direction and oversight for key functional areas (i.e. Packaging, Validation, Quality Control, Engineering, Information Systems)
• Understanding of principles of Validation and New Product Introduction
• Experience in change control, non-conformance, corrective and preventative actions, and validation practices.
• 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.
• 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.