Job Description:
As a Change Control Lead, you will be responsible for ensuring regulatory compliance, audit readiness, and promoting GMP awareness across the site. This includes owning and managing change controls for large strategic projects involving equipment, automation, and supply chain. You will also initiate, progress, and oversee GMP and non-GMP changes in systems like IPI, Vault QMS, and Enablon.
About You:
To succeed in this role, you will have a strong understanding of unit operations, validation, GMP/GDP, regulatory requirements, and quality systems. You will also have proficiency in digital change control tools and experience in project environments with familiarity across the project lifecycle and change control execution. Excellent written and verbal communication skills are essential, as well as strong interpersonal and customer service abilities.
Requirements:
A degree in science or engineering is required, along with 3-8 years' experience in GMP/GDP settings. A hands-on approach to change control documentation is also necessary. Additionally, candidates must possess either a Stamp 1G or a Stamp 4 visa to work in the pharmaceutical sector in Ireland. We regret that we are unable to provide visa sponsorship at this time. Please note that this is a contracting opportunity, and candidates must apply via this advert or contact Grinne Hodnett for more information.
Key Skills:
* GMP
* Change control
* Project management system