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Change Control Coordinator

  1. Midlands (Ireland)
  1. Contract
Competitive
  1. CAPEX Projects
16-01-2024
33112

This vacancy has now expired

Change Control Coordinator - Carlow, Ireland - 11-Month 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 Coordinator. 

This a fantastic opportunity to be involved with the critical investment projects both on-site and remotely.


Role Summary:
  • Understand and progress change controls through both IPI and the Veeva Change Control Systems. 
  • Change control SME for the group – keeping up to date with all updates attending local COP Meetings on a regular basis for Regulatory Updates. 
  • Draft and Prepare change controls with the relevant team members.
  • Attend and Support the team at the relevant change Control meetings required to discuss the change.  
  • Progress change controls from initiation through to closure ensuring compliance to the site & global change control process.
  • Stay up to date with all the relevant upcoming and overdue change control records and aging records to react accordingly and ensure metric compliance.
  • Keep track of all change controls metrics for the group.
  • Partner with colleague’s cross-functionally (at site and above site) to ensure change controls are progressed in advance of the project need by date.
  • Be able to answer questions from batch release, questions from completion of the annual product review, and provide information if needed to support the regulatory filings.
  • Coordinating with the Project Engineer to manage the change control Work Stream from concurrence(approval) to closure.
  • Drive collaboration between groups within the Technical Engineering function proactively looking for synergies and innovative ways of doing work. 
 
Experience, Knowledge & Skills:
  • Bachelor’s degree or higher preferred; ideally in a Science, Engineering or Other Technical discipline
  • Would have engineering and/or validation experience in a sterile manufacturing environment and have a proven track record in management of change controls.
  • Change Control experience with IPI and Veeva an advantage.
  • Proficient understanding and experience of Sterile filling processes and equipment especially aseptic processing an advantage
  • Experience of executing and/or managing through equipment and process design and validation in a sterile environment an advantage
  • Good shipping/Filter/Cleaning validation knowledge required.
  • Lean Six Sigma Methodology experience desired.
  • Experience in audit preparation and execution desired

If this role is of interest to you, please apply now!

The candidate must have the rights to work in the location stated in the job advert.

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