Quality Assurance Specialist



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South Wales

Quality Assurance Specialist - Pharmaceutical - Permanent - South Wales

Our client is a leading global pharmaceutical company. At present, they are seeking a Quality Assurance Specialist on a permanent basis at their site in South Wales. Applicants will be degree qualified in a related science or engineering discipline and will have previous pharmaceutical industry experience working to GMP.

Responsibilities:

To play a lead role in the interpretation of business and regulatory (EU/US/Japan) guidelines and QA systems for input into compliance enhancement projects for facilities, processes and products, and to approve experimental and validation reports / protocols where appropriate.
To promote a sense of quality throughout the site departments so as to raise commercial manufacturing performance and eliminate waste caused by unnecessary compliance errors.
To conduct internal performance audits and follow up actions within site business units.
To lead nominated regulatory compliance projects and to ensure that the business meets its regulatory commitments through satisfactory completion of these projects.
To assist in the hosting of Client audits.
To review non-compliance identified by audit, deviations and complaints, and use technical / professional judgment to make the appropriate product quality decisions (in association with Quality Management), and to initiate and promote quality improvements to prevent re-occurrence.
To ensure the review and approval of all documentation relating to manufacturing to support their continued processes to meet the business needs.
To ensure that products were manufactured in accordance with specified requirements and cGMP.
To play a lead role in the efficient review and approval of batch documentation to ensure deadlines are met and where required, effective and efficient correction of QP review comments.
To provide statistical trending reports on quality key performance indicators and to initiate corrective and preventive actions based on this data. To generate a monthly report on the key activities and key performance indicators for the area.
To liaise with the operational groups regarding relevant compliance topics £28000 - £40000/annum

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