We are seeking a seasoned professional to fill the role of Change Control Manager. This exciting opportunity will involve ensuring regulatory compliance, audit readiness, and promoting GMP awareness across our site. As a key member of our team, you will own and manage change controls for large strategic projects involving equipment, automation, and supply chain.
Responsibilities include:
* Initiating, progressing, and overseeing GMP and non-GMP changes in systems like IPI, Vault QMS, and Enablon
* Collaborating with stakeholders for impact assessments, approvals, and task alignment across change lifecycles
* Driving process optimization, managing project schedules, and supporting safety and quality initiatives onsite
To be successful in this role, you will possess a strong understanding of unit operations, validation, GMP/GDP, regulatory requirements, and quality systems, with proficiency in digital change control tools. Additionally, you should have experience in project environments with familiarity across the project lifecycle and change control execution.
We offer a competitive package, including a degree in science or engineering, 3-8 years' experience in GMP/GDP settings, and a hands-on approach to change control documentation. If you are looking for a challenging opportunity that aligns with your skills and experience, please apply today.