QS Controller (12mth Fixed Term Contract)
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? A growing and innovative company based in Waterford, Eirgen Pharma develops and supplies specialty care medicines to patients in more than 50 countries worldwide. Our guiding principle is to improve and enhance the lives of patients, whether they be reached directly or through our contract manufacturing and development customers across the pharmaceutical industry.
Eirgen’s Waterford campus consists of a state-of-the-art and globally-accredited manufacturing environment which provides tableting, capsule, soft gel manufacturing and packaging capabilities. Our R&D Team accommodates our development and analytical scientists working on the next generation of treatments for the company and its clients.
About the Job
In this role you will implement and coordinate the Quality Systems documentation control processes and standards and support the Quality Systems department in all activities.
You will:
- Coordinate documentation control standards
- Implement and coordinate 5S standards within documentation vault
- Control and reconcile completed Master Batch Documentation
- Coordinate and reconcile hard copy managed print documentation
- Control and reconcile issued GxP logbooks
- Reconcile and track completed GxP documentation
- Control and reconcile QS controlled numbering Indexes
- Manage and reconcile GxP documentation indexes
- Generate and issue metrics relating to QS activities, as required
- Assist in the preparation for customer / regulatory inspections to ensure efficient and accurate document retrieval.
- 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
- Reports any Defects
- If Unsure about safety requirements - ask
About you
You have a minimum of 3 years administrative experience in the Pharma industry, specifically within a Quality Systems environment.
You have a strong compliance mind-set, and attention to detail, along with excellent organisational skills. You will draw from your many skills such as planning, multi-tasking, time management and 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 up to date CV to opportunities@eirgen.com including the job title in the subject.