Reach your career goals with Eirgen Pharma, your future could be here
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?
Eirgen was founded in 2005 and since then we have continually grown and now employ over 180 employees at our site in Waterford. Our strengths lie in our capability to rapidly introduce new products and add additional volume to existing products - ensuring supply for new product launches and expanding market opportunities.
What makes us different is that while we continue to grow our business, we have still maintained that small company feel to our culture which enables us to ensure that our employees are always front and centre in everything we do. By creating a progressive and dynamic working environment, where hard work and enjoyment aren't mutually exclusive, we have created a high performing, people-centric culture which allows us to work in an environment where the focus is always on ensuring that the patient comes first.
About the Job
In this role you will ensure that all quality systems are maintained in compliance with company, regulatory and health & safety requirements. Additionally, this is a key role for the site with regards to the design and mapping of our current quality system processes to meet current and future organization requirements.
You will:
* Assist with the design and mapping of current quality system processes to meet current and future organization requirements.
* Be 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.
* Oversee 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
* Provide administrative support for electronic management systems
* Investigate and evaluate any Quality System incident reports.
* Be change owner and evaluator for Quality System change controls.
* Continuously identify and implement system improvements.
* Generate and present company metrics.
* 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
* If Unsure about safety requirements - ask
About you
You are qualified to a minimum of degree level or have equivalent experience in a regulated environment. You possess strong technical ability to develop procedures and review processes. You have excellent cGMP guideline knowledge, as well as knowledge of QUMAS EDMS and change management systems.
You also have knowledge and experience of Microsoft products including Excel, Word & Power Point. You possess excellent written & verbal communication skills and can present complex data about processes in a clear, accurate and readable format that is appropriate for the intended audience. You have strong attention to detail and work effectively on your own as well as with others.
You have a quality and compliance mindset and will draw from many skills including adaptability, planning, multi-tasking and time management. You have strong initiative and form positive relationships, you enjoy collaborating, gaining knowledge, continuous improvement and solving problems.
Working at Eirgen – What to expect
At Eirgen, we have developed a diverse, people-centric, high-performance culture where people are enabled to achieve their potential.
If you are working at Eirgen, then we think you've got something special. Our employees are high-performing and work as part of a cohesive team, they are dedicated people who are driven to succeed and are rewarded with competitive salaries and an attractive range of benefits including opportunities for career progression and continuing education.
Apply for the above role by sending your CV to including the job title in the subject.