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Change Control Lead

  1. Ireland, Midlands (Ireland)
Clonmel
  1. Contract
Competitive
  1. Compliance / Quality Assurance
37396
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Change Control Lead - Ireland, Clonmel - 11 Months Initial Contract

Do you want to be involved with exciting pharmaceutical projects?

When it comes to the development and production of veterinary vaccines, our pharmaceutical client has the largest centre in the industry worldwide and is a Centre of Excellence; employing more than 1000 people. They are looking to add to their team and require a Change Control Lead.

Essential Duties and Responsibilities for this role include, but are not limited to, the following:
  • 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 optimisation opportunities where they arise. (e.g. Hierarchy or dependency optimisation, material control strategies).
  • Maintaining accurate task scheduling per project requirements.  Minimising 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.
Desirable 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.
  • Requires extensive experience.
  • Experience of working in a project environment.
  • Hands on attitude, specifically carrying out change controls to a very high standard.
  • Excellent oral and written communication skills in English.
  • High level of customer orientation/understanding.
If this role is of interest to you, please apply now!
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