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.
Education and Experience:
* 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 working in a project environment specifically in a pharmaceutical industry.
If interested in this posting please feel free to contact Avishek Singh at Avishek.singh@lifescience.ie or 0872827991 for further information.
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