Job Title: Change Control Lead
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Are you a seasoned professional with expertise in change control and project management? Do you have a passion for delivering high-quality results in a fast-paced pharmaceutical environment?
We are seeking an experienced Change Control Lead to join our team. As a key member of our operations department, you will be responsible for managing changes associated with large strategic projects.
Your primary focus will be on ownership and management of changes related to processes, equipment, automation, and supply chain or other technical functions as required.
You will work closely with cross-functional teams, including change initiators, subject matter experts, reviewers, approvers, and external manufacturing groups to ensure seamless execution of changes through the change control systems.
Key Responsibilities:
* Initiate, own, and manage changes through the change control systems
* Prepare and progress GMP and Non-GMP changes in IPI, Vault QMS, and Enablon systems
* Collaborate with stakeholders for impact assessment and task identification
* Liaise with relevant review board for approval
* Conduct impact assessments for relevant changes
* Align system release strategy with stakeholders/operations
* Identify and implement process optimization opportunities
* Maintain accurate task scheduling per project requirements
* Minimize overdue tasks through schedule management
* Engage with tier process to escalate changes or tasks that are off track
* Conduct safety and quality walkdowns as required
Requirements:
* Strong emphasis on change control documentation
* GMP/GDP background
* Degree in science and/or engineering-based discipline
* Minimum 3-8 years experience working in a project environment in the pharmaceutical industry
If you're looking for a challenging role that will utilize your skills and experience, we encourage you to apply.