Exciting Opportunity with a Pharmaceutical Organization
Duties
* Progress change controls through IPI and Veeva Change Control Systems, ensuring compliance to site and global processes.
* Serve as a change control SME for the group, staying up-to-date on updates and attending regular COP Meetings for Regulatory Updates.
* Collaborate with team members to draft and prepare change controls, ensuring timely progression.
* Attend change control meetings to discuss and finalize changes, ensuring metric compliance.
* Monitor and manage all relevant change control records, proactively addressing aging records to maintain compliance.
* Track and report on change controls metrics for the group, identifying areas for improvement.
* Partner cross-functionally to ensure change controls are progressed in advance of project deadlines.
* Provide information and support regulatory filings, answering questions from batch release and annual product review.
* Coordinate with Project Engineers to manage change control work streams from concurrence to closure.
* Drive collaboration within Technical Engineering, assessing systems and processes to improve efficiency and compliance.
Education & Experience
* Prior experience in change control, preferably with IPI and Veeva.
* Considerable experience in a senior professional role, adding value to the business.
* Engineering and/or validation experience in sterile manufacturing environments, with a proven track record in managing change controls.
* Leadership experience, particularly in navigating change.