Job Description
We are currently recruiting for a highly rewarding opportunity with a leading Pharmaceutical organization based in Carlow.
This is an exceptional position for individuals looking to join a top multinational company that excels in its field.
Duties and Responsibilities
* Understand and progress change controls through both IPI and the Veeva Change Control Systems.
* Serve as a Change Control SME for the group, ensuring up-to-date knowledge of all updates and attending local COP Meetings on a regular basis for Regulatory Updates.
* Draft and prepare change controls with relevant team members.
* Attend and support the team at change control meetings required to discuss changes.
* Progress change controls from initiation through to closure, ensuring compliance with site and global change control processes.
* Stay informed about 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 colleagues cross-functionally (at site and above site) to ensure change controls are progressed in advance of project need by dates.
* Be able to answer questions from batch release, provide information for completion of annual product reviews, and support regulatory filings as needed.
* Coordinate with the Project Engineer to manage change control work streams from concurrence (approval) to closure.
* Drive collaboration between groups within the Technical Engineering function, proactively seeking synergies and innovative ways to work smarter and more efficiently while maintaining compliance.
Education and Experience Requirements
* Prior experience with IPI and Veeva in change control is advantageous.
* A senior professional with considerable experience in a comparable role, typically operating as a leader who adds significant value to the business.
* Engineering and/or validation experience in a sterile manufacturing environment, with a proven track record in management of change controls.
* Experience in leading through change would be beneficial.