Steven McDonnell

Experience

• 

  AstraZeneca

  Jul 2006 - now

  Responsible for the Quality management of assigned Supply Chains or 3rd party customers. Dependent on the areas of responsibility assigned, the role can include collaboration with Supply Chain management teams in Global Supplier Quality; supporting the GES PCO organization; supporting 3rd party externalisation transition teams and the demands of 3rd marketing authorisation holders. The Quality Account Manager is responsible for all Quality activities that directly support execution of the Product Supply Chains for Global External Sourcing, supply to customer (and/or AZ Site/ 3rdParty supply) covering end to end supply of the externally sourced products. This includes, but is not limited to Quality oversight, supporting Quality Directors during issue management of quality issues impacting the ability to provide the right product at the right time to the customer and taking the lead for GES in IMTs. They serve as the primary interface between Quality and the Supply Chain Leads/ 3rdParty Customers (as required); and as the Quality leader role in the escalation of quality supply chain issues. Show less As a Quality Facilitator aligned to the Packing PET circle I am accountable for all QA activities and decisions that directly support execution of the PET end to end process. The role is aimed to proactively build quality in to the products and processes and support the PET’s continuous improvement activities. Reporting directly to the PET QA Group Lead – aligned named QP and acting as the primary contact for all QA matters related to PET execution and is the primary link between the PET and other QA/QC support functions. The Quality Facilitator Key Accountabilities include: * Proactively reinforces the quality principles and provides independent assurance of the maintenance of the quality standards within the PET. * Timely and effective resolution of all quality issues within the PET to maintain product flow across the factory. * Representing the QA function within the PET Quality Meeting, advising on interventions to maintain / improve quality performance as relevant. * Maintaining and providing visibility of quality KPI’s and assessing the License to Operate within the PET. * Planning and leading internal and external inspection preparations as well as significant audits (both internal and external) to aid in developing improvement plans. Follow up any actions to ensure ongoing compliance. * Providing expert advice on Good Manufacturing Practice/Good Development Practice/Good Distribution Practice / Good Laboratory Practice within the site, with reference to Good Manufacturing Practice guidelines and regulations.* Reviewing Product Quality Reviews ensuring they are completed to plan and ready for QP approval. * Acting as BPO for key site Quality Management System Process. This is in addition to supporting all QMS within the Packing PET such as deviations, complaints, training. Show less

  • Global Supply Chain Quality Lead

    Apr 2023 - now

  • Quality Account Manager

    Nov 2020 - Jan 2024

  • Quality Facilitator

    Feb 2016 - Nov 2020

  • Quality Assurance Associate

    Nov 1997 - Nov 2020

  • Quality Control Manager

    Nov 1997 - Jun 2010

  • FLM

    Jul 2006 - Jul 2007