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Medical Products QA Officer

3 months ago

Runcorn, Halton, United Kingdom Koura Full time
You are purpose driven. Growth minded. Ready to stretch your potential.

That's the spirit of the community you'll find at Orbia:

where the purpose to advance life around the world drives our global team of over 23,000 every single day.

From creating solutions to deliver clean water, secure food supplies and reliable information to steering material advances that power the future of green and smart cities, transportation, and healthcare, we never settle for "good enough" when there's an opportunity to make life better.

Where purpose comes to life, it changes lives. This is what we live for.

Fluor and Energy Materials, an Orbia business, is looking for a Medical Products QA Officer to be based at our Rocksavage site, RuncornMain PurposeTo control the release of medical products prior to shipment.

To implement and maintain the Quality Management systems of the medical business to meet the requirements of cGMP and to pass all customer and regulatory audits.

Main ResponsibilitiesControl the formal release of medical grade products by approving or reject batches against operational and analytical standards so that all product is supplied in full compliance with appropriate regulatory and legal requirements of the pharmaceutical industry.

Support and maintain the Quality Management Systems so that compliance with appropriate QA standards is maintained in all work areas.

Manage appropriate documentation management systems for the business to ensure compliance with the required standards.

Identify improvements to Quality Management Systems and ensure that improvements targets are met, that system changes are implemented, and that such modifications are completed in full compliance with appropriate standards.

Devise, deliver and (where necessary) validate appropriate training packages across all European Business Quality Systems.

Develop an understanding of all appropriate business QA standards and requirements, so that Business' competency as a quality supplier is maintained and improved.

Working closely with Production and Sales teams to prioritize customer orders.
Support for internal audit and external customer audits.
Support maintenance of site EQMS documentation.
Assisting with site deviation, CAPA and Change controls.
QualificationsHNC in science related subject. Knowledge/ Experience RequiredcGMP and product release experience would be desirable.
Knowledge of 134a, 227ea operating and QC processes.2 years in QA related role is essential.

Behaviours that can help you succeed at Orbia:

Develop yourself & OthersFoster Collaboration & InclusionDrive ResultsProvide Vision & DirectionWe welcome purpose-driven dreamers, doers, and builders, recognizing that it takes difference to make a difference.

If you're ready to bring your skills, talents, and perspective to moving your career, the company, people, and the planet forward, we'd like to hear from you.

We believe that every voice matters; every community deserves respect; and every challenge is an opportunity and united by empathy, we are stronger for our different perspectives.

We are dedicated to building a more diverse, inclusive, and equitable workplace that supports the needs of all our employees regardless of their role, location, identity, and background.