We are seeking a highly skilled and experienced professional to lead our change control initiatives. The ideal candidate will possess a strong background in project management, with excellent communication and leadership skills.
Job Description
The Change Control Lead will be responsible for planning and executing all change control activities, ensuring compliance with regulatory requirements and promoting GMP awareness across the site. This role involves working closely with cross-functional teams, including maintenance, engineering, and quality assurance, to identify and implement process improvements.
Key responsibilities include:
* Ownership and management of changes associated with large strategic projects;
* Preparation and progression of GMP and Non-GMP changes through various systems;
* Collaboration with change initiators, subject matter experts, reviewers, approvers, and external manufacturing groups;
* Obtaining approval for change from relevant review boards;
* Liaising with stakeholders for impact assessment and task identification;
* Aligning system release strategy with stakeholders/operations;
* Identification and implementation of process optimization opportunities;
Required Skills and Qualifications
To succeed in this role, you will require:
* A degree in a science or engineering-based discipline;
* Minimum 3-8 years of experience in a project environment, preferably in a GMP/GDP setting;
* Strong understanding of unit operations and plant equipment;
* Knowledge of validation processes and regulatory requirements;
* Excellent communication, project management, and interpersonal skills;
* Leadership and customer service skills;
Benefits
We offer a competitive package, including paid holidays and parking benefits.