Job Description
An amazing opportunity has arisen for a Change Control Topic Lead.
Key Responsibilities
* Lead and maintain the change control business system (as Site Topic Lead for QMS Topic 3.4).
* Initiation, ownership and management of changes as required.
* Provide oversight, input, and guidance on change requests in terms of technical content, business process and the change control application.
* Liaise with the global business process owners and change control Community of Practice to resolve issues and strive for continuous improvement.
* Provide mentoring/hypercare as required, and complete administration activities on behalf of site users of change control systems.
* Attend community of practice meetings for change control, and champion global directives for improvements to business systems and processes.
* Owner and chair of the site Change Collaboration Meeting, and key attendee of Supplier Change Evaluation meetings.
* Attend Tier 3 to discuss endorsements for all Change Request with potential regulatory impact.
* Generate and monitor monthly change control metrics, and review and respond to Quality Council metrics.
* Provide guidance to change initiators/owners and advise on monitor and management of changes in change control applications.
* Attend Quality Council and complete annual review for change control as Site Topic Lead.
* Provide support as needed to pre-PAI, PAI and GMP inspections, both on-site, remote and paper based inspections.
Requirements
* Third-level qualification in a Science or Engineering discipline or a related field.
* 5+ years experience in a related discipline.
* Excellent communication skills, oral & written.
* Project Management skills.
* Decision making and problem solving skills.
* Leadership principles.
* Quality Policies and Procedures.
* cGMP and Manufacturing policies & procedures.
* Team work skills and ability to work across boundaries.
About Us
We are a company that is committed to 'Inventing for Life' in all that we do. We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world's most challenging healthcare needs.
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment.
If you are ready to invent solutions to meet unmet healthcare needs, impact the future by driving one of the world's leading healthcare companies, and inspire your team to reach their full potential and push the boundaries of science and technology, please apply today.