QA Documentation Specialist Nr ref.: /JOBS.pl In this role, you will have responsibility for the following; Key member of the Operations Management Team and Corporate Quality Team. ISO9001 Management representative (ISO9000, 22.214.171.124, ISO 9001, 5.5.2), ISO 13485. Control of the Quality Manual including preparation, revision and execution. Responsible for organising Management Review and compiling and reporting on the performance of the quality system. Management of the product review and release system and signature on Certificates of Conformity. Management of Change Control and Document Control Systems. Issuing, control and filing of all batch related documentation. Responsible for final sign-off on all product labels, package inserts and Marketing Material. The organisation of product and facility inspection, preparation of procedures and instructions including certification assessment and surveillance audits, FDA inspections, other regulatory inspections and supplier audits. Ensuring that validations are performed on equipment, processes and software used in manufacturing and testing of product. The Management of non-conformance and corrective and preventative action systems including the control of further processing and delivery of non-conforming product until any deficiencies or unsatisfactory conditions have been corrected. Responsible for coordination of issuing Product Safety Notifications or Product Recalls as well as Medical Device Reporting (MDR) with the Vice President of Regulatory Affairs. Key participant in design control. Assist with FDA regulatory submissions with the Vice President of Regulatory Affairs. This is a senior role with responsibility for all aspects of quality. We are searching for a high calibre candidate with the following background and experience: Primary degree qualification in a science, engineering or business discipline or equivalent in terms of relevant operational experience 5-7 years + industrial experience with preferably three years or more in the IVD industry. Must have experience in project management of change programs Firsthand experience of audits by regulatory authorities. Ideally will have hosted and lead FDA and other regulatory authority audits. Extensive experience of developing and delivering effective training on Quality Systems and Processes Demonstrated track record and success in team building skills Demonstrated experience of people management For more information and to apply for this role please call Stephanie on 1 or e-mail Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. Tel: 1 Kontakt: Aplikuj teraz Ogłoszenie pochodzi z serwisu Jobs.pl .
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