We are seeking a skilled professional to join our Pharmaceutical organization based in Carlow, Ireland. This exciting opportunity is perfect for individuals looking to work with a leading multinational that excels in its field.
Duties
* Manage and progress change controls through the IPI and Veeva Change Control Systems.
* Serve as a change control subject matter expert for the group, staying up-to-date on updates and attending local Committee of Professionals (COP) Meetings regularly for Regulatory Updates.
* Draft and prepare change controls in collaboration with relevant team members.
* Attend and support team members at change control meetings to discuss changes.
* Ensure compliance with site and global change control processes by progressing change controls from initiation to closure.
* Stay current with all relevant upcoming and overdue change control records and aging records, reacting accordingly to ensure metric compliance.
* Monitor and track change controls metrics for the group.
* Partner with colleagues across functions (site and above site) to ensure change controls are progressed in advance of project need-by dates.
* Provide information and answer questions related to batch release, annual product review completion, and regulatory filings.
* Collaborate with the Project Engineer to manage the change control work stream from concurrence to closure.
* Foster collaboration between groups within the Technical Engineering function, identifying synergies and innovative ways to work more efficiently while maintaining compliance.
Requirements
* Prior experience with change control using IPI and Veeva is advantageous.
* Considerable experience in a comparable role, typically operating as a senior professional and adding significant value to the business.
* Engineering and/or validation experience in a sterile manufacturing environment with a proven track record in managing change controls.
* Leadership experience in driving change would be an advantage.