Job Description:
We are seeking an experienced professional to join our Pharmaceutical organization based in Carlow.
This is an excellent opportunity for someone who wants to work with a leading multinational company that excels in its field.
Duties and Responsibilities:
1. Progress change controls through the IPI and Veeva Change Control Systems, ensuring compliance to site and global standards.
2. Serve as a Change Control SME for the group, staying up-to-date with updates and attending local COP Meetings on regulatory matters.
3. Draft and prepare change controls in collaboration with team members.
4. Attend and support team members at change control meetings to discuss changes.
5. Ensure timely progression of change controls from initiation to closure, adhering to site and global change control processes.
6. Maintain awareness of upcoming and overdue change control records, and aging records to react accordingly and ensure metric compliance.
7. Track change control metrics for the group.
8. Cross-functionally collaborate with colleagues (at site and above site) to advance change controls before project need-by dates.
9. Answer questions from batch release, annual product review, and provide information to support regulatory filings as needed.
10. Coordinate with the Project Engineer to manage the change control work stream from concurrence to closure.
11. Promote collaboration between groups within the Technical Engineering function, identifying synergies and innovative ways to work smarter and more efficiently while maintaining compliance.
Requirements:
* Change control experience with IPI and Veeva is advantageous.
* Considerable experience in a comparable role, typically operating as a senior professional 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 during periods of change would be beneficial.