Job Summary
We are seeking an experienced professional to join our team at a leading multinational Pharmaceutical organization based in Carlow.
Duties and Responsibilities
* Progress change controls through IPI and Veeva Change Control Systems.
* Act as a change control Subject Matter Expert (SME) for the group, keeping up-to-date with all updates and attending local COP Meetings for Regulatory Updates.
* Draft and prepare change controls with relevant team members.
* Attend and support the team at change control meetings to discuss changes.
* Progress change controls from initiation to closure, ensuring compliance to site and global change control processes.
* Maintain awareness of upcoming and overdue change control records and aging records to react accordingly and ensure metric compliance.
* Monitor change control metrics for the group.
* Collaborate with colleagues cross-functionally to ensure change controls are progressed ahead of project need by dates.
* Provide information to support regulatory filings, answer questions from batch release, and complete annual product reviews.
* Coordinate with Project Engineers to manage change control work streams from concurrence to closure.
* Foster collaboration between groups within Technical Engineering, identifying synergies and innovative ways to improve work efficiency while maintaining compliance.
Requirements
* Change control experience with IPI and Veeva is advantageous.
* Significant experience in comparable roles, typically operating as a senior professional and adding value to the business.
* Engineering and/or validation experience in sterile manufacturing environments with proven track records in managing change controls.
* Leadership experience in managing change would be beneficial.