We’re currently recruiting for an exciting opportunity with a Pharmaceutical organization based in Carlow. 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.

Duties

• 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. Constantly assessing our systems and processes to see what improvement we can make to work smarter and more efficiently while all the time being compliant

• Change Control experience with IPI and Veeva an advantage
• Considerable experience in a comparable role; would typically have experience operating as a senior professional and adding considerable value to the business
• Would have engineering and/or validation experience in a sterile manufacturing environment and have a proven track record in management of change controls.
• Experience in leading through change would be an advantage