Quality and Compliance Systems Specialist
Our client is looking for a Quality and Compliance Systems Specialist to join their team as a contractor
Salary: €23 - €25 per hour
Our client is a leading biologics company who has continued to grow and diversify to serve patients around the world. Their site in Waterford comprises of almost 800 employees who work together at a state of the art biopharmaceutical and medical device campus.
The Quality Systems team ensures customer and vendor complaints are managed in a manner which meets cGMP requirements. The team also lead activities required to maintain an agile, efficient Quality System to meet the site's needs.
This position will involve the maintenance of customer complaints and involvement in process improvements of the Site's QMS (Quality management System) when required.
* To ensure effective quality systems are implemented meeting industry standards and all cGMP requirements.
* Co-ordinate all Complaints from customers and other Sanofi sites ensuring they are appropriately logged, investigated, reported and trended ensuring collaboration with Regulatory and QP function.
* Manage and improve the Site audit Readiness Program with cross functional ownership, effectively leading all external regulatory and corporate audits at Waterford.
* Supporting and providing appropriate information to support Product Performance Reviews (PPR) and complaint trending requirements
* Ensure compliance to cGMP at all times.
* One/two years' experience in a similar role with sterile Manufacturing experience (preferable)
* Excellent communication skills (interpersonal, presentation & writing)
* Works well with others at all levels of the organization, across multi-sites, and in a multi-national environment
* Initiative - able to work in a self-directed manner to see issues through to completion
* Education: Third level qualification (degree in science or related discipline) or appropriate relevant experience supplementing lower grade scientific qualification
If you feel that this roles aligns with what you are looking or if you'd like to get more please respond to this advert with an updated CV or get in touch with Elidyah at [email protected]
We look forward to receiving your application