Quality Specialist

Clinigen is a rapidly growing global specialty pharmaceutical and services company with a unique combination of businesses. Our divisions operate in a complex global regulatory environment and ensure that vital medicines are delivered securely on time and wherever they are needed in the world.

We are currently 1,100 people headquartered in the UK with global offices in the US, EU, JAPAC and South Africa. Clinigen has grown rapidly since it began in 2010 and is positioned well for an exciting future of continued expansion.

To support our growth, we are seeking a confident and proactive Quality Specialist to join our Quality team based in Dublin to support the business in relation to all Quality matters detailed below.

Document Processing and Document Management

• Manage the business requests for document updates, document obsoleting and document archiving in eQMS
• Key contact and administrator for the archiving storage areas
• Provide training to others when required

eQMS Management

• Primary eQMS admin support (workflow resets, issues log and maintaining the associated work instructions)
• Gate keeper for the eQMS related SOPs
• Primary eQMS support for UAT testing
• Provide training to others when required
• Manage the relationship with external service providers

Training Management in the Learning Management System (LMS)

• Keep training matrices relevant and up to date
• Ensure employee names, roles and reporting structure is current within the LMS
• Manage the business requests for the creation of all courses for the SOPs & Policies from the eQMS and other Clinigen training courses
• Key LMS admin for the relevant Clinigen sites which operate under a centralized function
• Primary support for improvements and further rollout of the LMS across the Global Clinigen Sites
• Train the local LMS admins across the Global Clinigen Sites

• 27 days holiday plus 8 bank holidays
• Life assurance 4 x annual salary
• Annual salary review
• Independent financial advice service
• Long service awards
• Recognition scheme & employee of the year awards