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Change Control Business System Lead
2 weeks ago
As a Change Control Business System Lead at Merck Gruppe - Msd Sharp & Dohme, you will play a key role in maintaining the change control business system as Site Topic Lead for QMS Topic 3.4.
Your responsibilities will include initiation, ownership, and management of changes as required, which may be related to processes (both commercialization and supply), cleaning, supply chain, or other technical functions.
You will provide oversight, input, and guidance on change requests in terms of technical content, business process, and the change control application.
Liaise with global business process owners and the change control Community of Practice to resolve issues and strive for continuous improvement.
In addition, you will provide mentoring/hypercare as required, complete administration activities on behalf of site users of change control systems, and attend community of practice meetings for change control.
Champion global directives for improvements to business systems and processes, and own and chair the site Change Collaboration Meeting.
Key attendee of Supplier Change Evaluation meetings, attend Tier 3 to discuss endorsements for all Change Request with potential regulatory impact, and generate and monitor monthly change control metrics.
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, and provide support as needed to pre-PAI, PAI, and GMP inspections.
