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Medical Products QA Officer

4 months ago

Runcorn, United Kingdom Koura Global Full time

Main Purpose

To 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 Responsibilities

* Control 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.

Qualifications

* HNC in science related subject.

Knowledge/ Experience Required

* cGMP and product release experience would be desirable.

* Knowledge of 134a, 227ea operating and QC processes.

* 2 years in QA related role is essential