We’re currently recruiting for an exciting opportunity with a Pharmaceutical organisation based in Tipperary. This is an excellent position for anyone who is looking to join a leading multinational who are addressing some of the world’s most challenging healthcare needs.

Duties:

• Ownership and management of changes as associated with large strategic large projects. Changes may be related to processes e.g. equipment, automation and supply chain or other technical functions as required.
• Responsible for initiation, ownership, and management of changes through the change control systems.
• Preparation and progression of GMP and Non GMP changes in IPI, Vault QMS and Enablon systems.
• Collaboration with change initiators, subject matter experts, reviewers, approvers, and external manufacturing groups through the life cycle of relevant changes.
• Obtain approval for change from relevant review board.
• Impact assessment for relevant changes.
• Liaise with stakeholders for impact assessment and task identification.
• Aligning of system release strategy with stake holders/ operations.
• Identification and implementation of process optimization opportunities where they arise. (e.g. Hierarchy or dependency optimization, material control strategies).
• Maintaining accurate task scheduling per project requirements. Minimizing the number of overdue tasks through schedule management.
• Engagement with the tier process to escalate changes or tasks that are off track.
• Conduct safety and quality walkdowns, as required.

• Ideally candidates should have a strong emphasis on change control documentation, a GMP/GDP background and a degree in a science and or engineering based discipline.
• Minimum of 3-8 years’ experience with experience of working in a project environment in a pharmaceutical industry.