AbbVie CMC QA EU Validation Lead in Santry, Ireland
CMC QA EU Validation Lead
Ireland, Leinster, Santry
AbbVie employees work every day to discover and address many of the world's most pressing health challenges. Our work helps people live better lives. When you have patients depending on your solutions, you look for the best people to be part of the team. We are always looking for talented people to join our team and, when we find them, we make it our business to treat them well.
We are currently sourcing a CMC QA EU Validation Coordinator to coordinate the development and maintenance of the company’s validation program in compliance with all applicable regulatory and AbbVie requirements to ensure flawless NPI PPQ execution across the network operations manufacturing sites. In this role, you will lead communication planning, preparation and actions to ensure improvements are harmonized and shared across the manufacturing network and the quality system documents and IT systems are aligned accordingly.
This role can be based in Ireland (Santry, Sligo or Cork), Germany or Italy.
Develop and implement global strategic initiatives to ensure New Product Introduction PPQ’s are executed RFT, including:
Co-ordination and direction of the qualification of site equipment, facilities, utilities, processes, cleaning and software in compliance with AbbVie policies, FDA, European cGMP and GAMP standards to ensure they meet the requirements for NPI’s.
Collaborate with partners including Global and Site Operations and QA, S&T and R&D to drive broader network efficiency
Review / Approval of Project Validation Plans associated with New Product Introductions.
Review / Approval of validation protocols and final reports associated with New Product Introductions to cGMP standard
Review / Approval and Oversight of validation change control processes across all sites with New Product Introductions
Leading process improvement initiatives identified
Development and monitoring leading indicators of validation execution performance. Development of actionable resolution plans where needed
3rd level qualification in engineering or scientific discipline.
A minimum of 10 years experience in a cGMP regulated environment, with validation activities demonstrated successfully.
Requires innovative thinking, where new and untested solutions are proposed, demonstrated and implemented on a regular basis.
Requires proven problem solving skills and the ability to adapt to new requirements.
Is results driven striving to meet all targets and standards.
Strong communication skills both verbal and written are required for the execution of this role.
Strong interpersonal skills are required.
This position is crucial in identifying validation requirements and developing actionable plans for successfully delivery across the network.
Ensures all procedures/policies and guidelines are adhered to.
Is a Global SME on all Process Validation issues and provides guidance on same.
Provide technical leadership to the AbbVie network and collaborates with key site stakeholders.
Responsible for the presentation of technical data to stakeholders to ensure prompt decisions.