Change Control Specialist
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We are currently recruiting for an exciting opportunity with a leading multinational pharmaceutical organization based in Tipperary.
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This is an excellent position for anyone looking to join a company addressing some of the world's most challenging healthcare needs.
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The successful candidate will be responsible for ownership and management of changes associated with large strategic projects, including process changes, equipment, automation, supply chain, and other technical functions.
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Key duties include:
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* Initiation, ownership, and management of changes through the change control systems;
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* Preparation and progression of GMP and Non-GMP changes in IPI, Vault QMS, and Enablon systems;
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* Collaboration with change initiators, subject matter experts, reviewers, approvers, and external manufacturing groups;
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* Obtaining approval for change from relevant review boards;
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* Impact assessment for relevant changes;
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* Liaising with stakeholders for impact assessment and task identification;
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* Aligning system release strategy with stakeholders/operations;
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* Identification and implementation of process optimization opportunities;
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* Maintaining accurate task scheduling per project requirements;
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* Minimizing the number of overdue tasks through schedule management;
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* Engagement with the tier process to escalate changes or tasks that are off track;
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* Conducting safety and quality walkdowns as required;
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* Education and Experience: A strong emphasis on change control documentation, a GMP/GDP background, and a degree in a science or engineering-based discipline;
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* A minimum of 3-8 years of experience working in a project environment in the pharmaceutical industry.
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If you have the necessary skills and qualifications, please contact us for further information.
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