About the job
Quality Systems Officer
Reach your career goals with Eirgen Pharma, your future could be here!
About Eirgen Pharma
Would you like to be part of a company that has the courage, innovation, and capability to improve and enhance patient lives across the globe?
Founded in 2005, Eirgen Pharma employs over 180 people in Waterford. We combine the agility of a small company with the ambition to deliver high-quality medicines globally — all within a collaborative, people-focused culture.
About this Opportunity
You will provide process engineering support and project leadership to support internal customers in the day to day operations of the organization and site capital projects, enabling delivery of high quality process centred projects safely, on time and within budget.
Key Responsibilities:
- Assist with the design and mapping of current quality system processes to meet current and future organization requirements.
- Responsible for ensuring that all quality systems are in compliance with data integrity requirements.
- Support administrative resources across the organization to ensure consistency and linking of processes and documents.
- Investigator and evaluator for any Quality System incident reports
- Change Owner and Evaluator for Quality System change controls
- Identifies and implements system improvements
- Supports the collection, collation and reporting of site quality metrics
- Provide support in the development of procedures and instructional documentation.
- Provide operational and project support, where required
- Administrative support for electronic management systems
- Continuously identify and implement system improvements.
- Support in the generation and presentation of company metrics.
- Support in completion of documentation control tasks
- Ensure that all work carried out is in compliance with the required standards conforming to company, cGMP, cGLP, SOP’s, regulatory regulations and guidelines, safety and environmental guidelines
Health & Safety:
- Implement Safety requirements as per site documentation including SOPs, Safety Statement and COPs
- Continuously promote a positive safety culture by leading by example
- Reports any Defects and hazards
- If Unsure about safety requirements - ask
About You
- A third level education or equivalent work experience in a regulated environment
- Technical ability to develop procedures and review processes
- cGMP guideline knowledge
- Knowledge and experience using 21 CFR Part 11 compliant eSystems
- Well-developed, proven experience with Microsoft Office suite
- Good organizational and interpersonal skills will be required
- Excellent communication and presentation skills
- Ability to define and manage own tasks and schedules is essential
Why Join Eigen Pharma?
- You will work as part of a collaborative analytical team, contributing to high-quality data delivery in a fast-paced, GMP-regulated environment
- Opportunity to work on development-stage and commercial products
- Collaborative and quality-driven environment
- Excellent benefits, pension, health insurance, social club, canteen facilities
Apply for the above role by sending your CV to opportunities@eirgen.com including the job title in the subject.