About Eirgen Pharma
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
The QA Officer supports the QA Team Leader & Manager with the development, implementation and maintenance of the quality standards and systems to ensure that products comply with marketing authorisations, documentation, specifications and cGMPs.
Responsibilities include, but are not limited to:
* Support manufacturing areas in terms of QA, including but not limited to the following:
* Documentation review
* Assessment of GMP/GLP events from a QA perspective.
* Utilise the Electronic Documentation Management System - QUMAS
* Check own work and that of others for accuracy prior to 'QA Authorisation' of documentation.
* QA reviewer of Trackwise Change Controls, Deviations and M&Is
* Progress Trackwise actions and attach evidence as required.
* Perform internal audits as scheduled in Eirgen with specific responsibility for the manufacturing & laboratory areas.
* Ensure that all work carried out in Eirgen is in compliance with the required standards conforming to company, cGxP, SOPs, regulatory regulations and guidelines, safety and environmental guidelines.
* Report any safety or compliance issues as per Eirgen procedures.
* Prepare and review batch packs for QA/ QP release as per procedure.
* Liaise with operations / laboratory personnel to ensure regulatory and quality requirements are met.
* Assist with review of Submission & Clinical Documentation in support of license applications and customer requirements.
* Non-compliance reporting and corrective action / continuous improvement implementation.
* Operation of Eirgen SAP (ERP System) Quality function as per procedures.
* Liaise with Laboratory personnel on the progression of OOS/OOT and KLE investigations as per procedures.
* Identify and make recommendations for improvements as part of a team within or outside the department in order to ensure continuous improvement.
* Check your own work and that of others for accuracy.
* Assist in the preparation for customer/ regulatory inspections
* Attend a number of cross functional team meetings as a Quality Assurance representative
* Perform additional team tasks as agreed to support effective running of the Business.
* Compile and deliver quality based training with the company.
* Implement safety requirements as per site documentation including SOPs, and Safety Statement and report any hazards.
About You
You have a third level qualification incorporating Quality Assurance (QA)/Quality Management (QM) or possess a standalone QA or QM module. Preferably, you have at least 2 years' experience in a Pharma/GMP related role, with experience of desktop and internet-based software applications (e.g. EDMS - Electronic Document Management System QUMAS, SAP, MRP system, and Trackwise eQMS) along with Lead Auditor Training an advantage.
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.
Direct applicants only.
We are not accepting assistance from recruitment agencies at this time.