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QA/RA Officer
Location:
Manchester
Description:
QA/RA Officer Salary 28:30K dependent on experience Full time, Permanent Manchester, M13 9XX Our Genedrive(R) device is a rapid, versatile, simple: to: use and robust point: of: need molecular diagnostics platform for use in patient stratification of patients (genotyping), pathogen detection and other clinical indications such as infectious disease detection. Job summary The QA/RA Officer will support the Director of Quality and Regulatory Affairs by assisting in maintaining an appropriate quality environment for the development and manufacture of products that meet the requirements of European and other Regulators as the Company moves towards becoming a leading clinical diagnostics company. The role is split predominately 70 quality and 30 regulatory. Essential Functions Participate fully as a member of the Quality Team within and across the business. Provide Quality and Regulatory support to all departments within the business. Collaborate with internal and external stakeholders to ensure all our processes comply with the relevant standards and regulations. Collate and provide KPIs, trend data and statistical analysis for Management Review and any other review boards where requested. Provide guidance on Risk Management activities. Provide guidance, support and maintain the Non: Conformance/Deviation system. Provide guidance and perform Root Cause Analysis into CAPA investigations. Assist in the review of Technical, Medical Device and Design History Files. Create, review, advise and provide guidance on interpretation of SOPs. Review, advise and provide guidance on interpretation of Regulatory requirements. Review Verification and Validation Data Reports and SOPs and provide support during the Validation activities. Provide assistance with the maintenance of the electronic and hardcopy record archives. Perform internal Audits to a predefined schedule Participate and support in external Inspections and Audits with clients,. Visit ListedBuy for more information.
Posted:
February 1 on ListedBuy
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QA/RA Officer is a Other Art & Media Jobs QA Job located in United States. Find other listings like QA/RA Officer by searching Oodle for Other Art & Media Jobs QA Jobs.