Specialist QA TS

Career Category

Job Description

Specialist QA Technical Support NPI

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 peoples lives. A biotechnology pioneer since 1980 Amgen has grown to be one of the worlds 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 an 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 peoples 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.

The Quality Assurance Technical Support Specialist NPI (New Product Introduction) 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. This is a unique opportunity to play a key role in a high-impact function providingQuality Oversight for validation and technology transfer activities supporting the introduction of new lines/equipment new product introduction and product lifecycle changes. This role requires a strong focus on QA leadership in the qualification of facilities equipment and process validation ensuring all qualification and validation activities meet Amgen and regulatory standards.

Key Responsibilities

• Provide overall quality direction and oversight for key functional areas (i.e. PD Validation and Operations) ensuring that programs policies and procedures are robust and in keeping with regulatory and Amgen expectations.
• Serve as the QA Lead for technology transfer and NPI activities providing quality oversight throughout process validation and product lifecycle introduction.
• Serve as the QA point of contact and decision-maker during validation execution ensuring adherence to regulatory and internal standards.
• Lead QA review and approval of technology transfer and validation documentation including process descriptions Validation Plans protocols validation reports and risk assessments.
• Lead QA review and approval of SAP BOMs MBRs and recipes.
• Partner cross-functionally with PD Engineering and Operations teams to ensure all NPI activities are compliant with regulatory and site quality requirements.
• Provide QA oversight for Change Controls CAPAs and Deviation Investigations.
• Support inspection readiness and regulatory audits representing QA for validation and NPI areas.
• Support a safe working environment by complying with all pertinent environmental health/safety practice rules and regulations
• 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 in a Science-related discipline.
• Minimum of 8 years relevant experience in the pharmaceutical or biotechnology industry
• In-depth knowledge of applicable regulatory requirements and experience with regulatory inspections.
• Experience working in aseptic operations relating to vial and syringe filling.
• Understanding of principles of Validation and New Product Introduction
• Proven experience in Quality Systems (change control non-conformance corrective and preventative actions).
• Strong organizational skills with the ability to manage tasks through to completion.
• Ability to work independently and remotely with minimum direct supervision.
• Strong critical thinking and problem-solving abilities
• 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.