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Rachel Kent
Life Science

+353 87 427 8808
[email protected]
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Details

Quality Specialist - Change Control Lead


Reference:RK22648 Location: Tipperary
Qualification:DegreeExperience:5-7 Years
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: Project Manager

Quality Specialist - Change Control Lead
RK22648
Contract – 11 months
Tipperary


We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Tipperary. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.


The successful applicant will be responsible for initiation, ownership and management of changes through the change control system. Collaboration with change initiators, subject matter experts, reviewers, approvers and external groups through the life cycle of relevant changes. Liaising with project teams to enable schedule adherence as it relates to turnaround of changes.


Duties:

• Ownership and management of safety, quality and environmental changes, as associated with large strategic projects. Changes may be related to processes e.g. equipment, automation, utilities and facilities, or other technical functions as required.
• Initiation of changes, where deemed appropriate.
• Impact assessment for relevant changes.
• Collaboration with Change Initiators, SMEs, Reviewers, Approvers and other stakeholders to enable successful and efficient change progression.
• 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.
• Overall schedule management for change control lifecycle including metric and management reporting from multiple change control platforms.


Experience and Education:

• Degree or post-graduate qualification in Science, Pharmacy or Engineering field
• 3+ years’ experience, ideally in Quality within the Biological and/or pharmaceutical industry.
• Have a strong emphasis on Change Control Documentation with a GMP/GDP background in Quality
• Experience of working in a project environment.


If interested in this posting please feel free to contact Rachel Kent at Life Science Recruitment for further information.