LSC have a great contract opportunity for a Change Control Lead to join a top pharmaceutical company based in Tipperary. The site supports the complete pharmaceutical small molecule process for Phase III clinical to product release and market support. On site processes include API manufacture, formulation, OSD tableting, packaging and global logistics & distribution. The facility takes in raw chemicals and ships finished medicines to end users. This site has grown from an API site to a strategically important campus that supports critical stages of the company's drug lifecycle.
If you have a degree in Science or Quality and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Ensure regulatory compliance, audit readiness, and promote GMP awareness across the site.
- Own and manage change controls for large strategic projects involving equipment, automation, and supply chain.
- Initiate, progress, and oversee GMP and non-GMP changes in systems like IPI, Vault QMS, and Enablon.
- Collaborate with stakeholders for impact assessments, approvals, and task alignment across change lifecycles.
- Drive process optimization, manage project schedules, and support safety and quality initiatives onsite.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Technical Expertise: Strong understanding of unit operations, validation, GMP/GDP, regulatory requirements, and quality systems, with proficiency in digital change control tools.
- Project & Process Knowledge: Experience in project environments with familiarity across the project lifecycle and change control execution.
- Communication & Collaboration: Excellent written and verbal communication skills, with strong interpersonal and customer service abilities.
- Analytical & Problem Solving: Skilled in data collation, decision-making, time management, and attention to detail to ensure high-quality outcomes.
- Educational & Experience Requirements: Degree in science or engineering, 3-8 years' experience in GMP/GDP settings, and a hands-on approach to change control documentation.
Please note that for our contracting opportunities in the pharmaceutical sector in Ireland, candidates must possess either a Stamp 1G or a Stamp 4 visa. We regret that we are unable to provide visa sponsorship at this time. Thank you for your understanding.
Apply via this advert or contact Gráinne Hodnett on 021 4777 329 if you have any more questions about this opportunity!
