Job Title:
Change Control Specialist
We are currently recruiting for an exciting opportunity with a Pharmaceutical organization based in Carlow. This is an excellent position for anyone looking to join a leading multinational who excels in their field.
Duties:
1. Understand and progress change controls through both IPI and Veeva Change Control Systems.
2. Act as the Change Control Subject Matter Expert (SME) for the group, ensuring up-to-date knowledge of all updates, and attending local COP Meetings on a regular basis for Regulatory Updates.
3. Draft and prepare change controls with relevant team members.
4. Attend and support the team at change control meetings to discuss changes.
5. Progress change controls from initiation through to closure, ensuring compliance to the site and global change control process.
6. Stay up-to-date with all relevant upcoming and overdue change control records and aging records to react accordingly and ensure metric compliance.
7. Monitor and track all change controls metrics for the group.
8. Partner with colleagues cross-functionally (at site and above site) to ensure change controls are progressed in advance of the project need by date.
9. Provide information and answer questions from batch release, annual product review, and regulatory filings as needed.
10. Coordinate with the Project Engineer to manage the change control work stream from concurrence (approval) to closure.
11. Drive collaboration between groups within the Technical Engineering function, proactively seeking synergies and innovative ways to improve processes while being compliant.
Education & Experience:
1. Experience with IPI and Veeva is advantageous.
2. Considerable experience in a comparable role, typically with senior professional experience adding significant value to the business.
3. Engineering and/or validation experience in a sterile manufacturing environment with a proven track record in managing change controls.
4. Leadership experience through change would be beneficial.