Exciting Opportunity with a Pharmaceutical Organization
We are currently recruiting for an exciting opportunity with a leading multinational pharmaceutical organization based in Carlow. This is an excellent position for anyone who is looking to join a top-performing company.
Duties
* Progress Change Controls: Understand and progress change controls through both IPI and the Veeva Change Control Systems.
* Change Control SME: Act as a subject matter expert for the group, keeping up to date with all updates attending local COP Meetings on a regular basis for Regulatory Updates.
* Draft Change Controls: Draft and prepare change controls with the relevant team members.
* Support Change Control Meetings: Attend and support the team at the relevant change control meetings required to discuss the change.
* Ensure Compliance: Progress change controls from initiation through to closure ensuring compliance to the site & global change control process.
* Monitor Records: Stay up-to-date with all the relevant upcoming and overdue change control records and aging records to react accordingly and ensure metric compliance.
* Track Metrics: Keep track of all change controls metrics for the group.
* Cross-Functional Collaboration: Partner with colleagues cross-functionally (at site and above site) to ensure change controls are progressed in advance of the project need by date.
* Provide Information: Be able to answer questions from batch release, questions from completion of the annual product review, and provide information if needed to support the regulatory filings.
* Coordinate Change Control Work Stream: Coordinate with the Project Engineer to manage the change control work stream from concurrence (approval) to closure.
* Drive Collaboration: Drive collaboration between groups within the Technical Engineering function proactively looking for synergies and innovative ways of doing work. Constantly assess our systems and processes to see what improvements we can make to work smarter and more efficiently while being compliant.
Education & Experience
* Change Control Experience: Change control experience with IPI and Veeva is an advantage.
* Comparable Role Experience: Considerable experience in a comparable role; typically have experience operating as a senior professional and adding considerable value to the business.
* Engineering and/or Validation Experience: Engineering and/or validation experience in a sterile manufacturing environment with a proven track record in management of change controls.
* Leadership Experience: Experience in leading through change would be an advantage.