Stability Coordinator
Job Description
Our Carlow site, which broke ground in 2008, is a strategic manufacturing facility supporting the launch and commercial supply of vaccines, biologics, and small molecule drug products.
Since its establishment, the site has benefited from significant investment and is home to state-of-the-art manufacturing facilities, laboratories, and temperature-controlled warehousing. As a major employer in the Southeast region, the Carlow site attracts high-performing talent through strong collaborations with local universities and colleges.
We have a great opportunity for a Stability Coordinator to join our Carlow site and be the driving force behind the success of our Stability team.
As the Stability Coordinator role, your energy, knowledge and innovation will play a key role in delivering high standards of quality, compliance, and operational excellence.
Bring energy, knowledge, and innovation to carry out the following:- Coordinate daily, weekly and monthly stability activities for the stability program. This includes working closely with other internal departments and external stakeholders
- Lead daily workflows, assigning and distributing task to the team to improve efficiency
- Maintaining capacity plans for resourcing and chamber management in relation to Stability activities.
- Support stability-related investigations, ensuring all regulatory requirements, notifications, and timelines are met.
- Supporting the data entry and analytics of Stability test results from internal and external laboratories and partners.
- Maintaining and reporting metrics for overall site Stability Program at key forums like Quality Council and laboratory leadership meetings.
- Ensuring compliance with company policies, procedures, guidelines, and all relevant regulatory requirements. You will ensure all Stability activities are conducted safely, accurately, and in line with current internal and external standards.
- Support effective stakeholder communication to ensure stability objectives are achieved, using operational excellence tools such as daily management and leader standard work.
- Ensure strong customer focus, working closely with internal stakeholders and external laboratories to ensure testing requirements are met and timelines are achieved.
- Play a role in the Lab Transformation programme, helping to optimise, standardise, and digitise business processes within the Stability team.
- Champion continuous improvement, driving lean initiatives such as standardised work, digitisation, and knowledge management.
What Skills You Will Need
- Bachelor’s degree in engineering or science or equivalent experience.
- 5+ years of experience in the pharma industry.
- Demonstrated Team Lead experience
- Stability Coordination experience is essential
- Excellent communication skills to build strong cross functional relationships
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