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Avishek Singh
Life Science

00353872827991
[email protected]
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Details

Change Control Lead


Reference:AS23388 Location: Tipperary
Qualification:DegreeExperience:See description
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: Controls Engineer

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 experience of working in a project environment in a pharmaceutical industry.

If interested in this posting please feel free to contact Avishek Singh at [email protected] or 0872827991 for further information.