Job Description
We are currently recruiting for a highly skilled professional to join our Pharmaceutical organization in Carlow.
This is an excellent opportunity for individuals who want to work with a leading multinational company that excels in its field.
Duties:
* Understand and progress change controls through IPI and Veeva Change Control Systems.
* Serve as the Change control SME for the group, ensuring up-to-date knowledge of updates and attending local COP Meetings on regulatory updates.
* Draft and prepare change controls with relevant team members.
* Attend and support team members at change control meetings to discuss changes.
* Progress change controls from initiation to closure, ensuring compliance with 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.
* Track change controls metrics for the group.
* Partner with colleagues across functions (site and above site) to ensure change controls are progressed ahead of project need by dates.
* Provide answers to questions from batch release, annual product review completion, and support regulatory filings as needed.
* Coordinate with Project Engineers to manage change control work streams from concurrence to closure.
* Drive collaboration between groups within Technical Engineering, proactively identifying synergies and innovative ways of working. Continuously assess systems and processes to improve efficiency while maintaining compliance.
Requirements:
* Change control experience with IPI and Veeva is advantageous.
* Considerable experience in a comparable role, typically as a senior professional adding significant value to the business.
* Engineering and/or validation experience in sterile manufacturing environments with a proven track record in managing change controls.
* Leadership experience in managing change would be beneficial.
Estimated Salary: €60,000 - €80,000 per annum