QUALITY SYSTEMS ASSOCIATE
Summary of Job To work with the Quality Manager and the Quality Team to develop and maintain an effective and compliant Quality System for Elstree facility. This will be achieved through the operational execution of key elements of the companies Quality System, including document control, QS training, change control, non-conformance or CAPA investigation and Customer complaints, to maintain compliance with ISO 13485 and FDA (21 CFR) part 820 requirements. Essential Duties & Responsibilities Maintenance of document control system � paper and electronic. Writing, reviewing, distributing and filing/archiving of completed Quality System documents. Participate in documentation control activities, liaising with appropriate personnel to progress updates, approvals, in accordance with the company Quality System compliance program. Support certificate of compliance program, advising, liaising and coordinating local SMEs as necessary to maintain effective and compliant processes. Complete the review and evaluation (Certificate of Compliance) of Issued and Effective Division and Corporate Procedures within specific area(s) of expertise. Support CAPA process. Evaluate corrective and preventive action responses to the assessment findings for adequacy, including root cause and timeliness. Elevate issues to management team, as appropriate. Support non-conformance or CAPA investigation as required. Manage the tracking, reporting, adequacy of actions, verification, closeout, and trending of all corrective and preventive actions using Trackwise. when applicable, participate in Complaints investigations and support Global Product Surveillance team. Support Change Control process, working with SMEs to assess and analyze risks prior to change control approval. Support the tracking, reporting, adequacy of actions, verification, closeout of all change controls. Generate, collect, monitor and trend quality data to support analysis of the Quality System performance for presentation at Management Review. Support Internal Audit program. Support incoming Notified Body and Regulatory Authorities inspections. Ensuring that the Quality Team and other appropriate staff are aware of any issues relating to the compliance status of assigned areas of the Quality System in a timely manner. Adherence to the companies relevant policies and procedures at all times, and notification of any deviations/ exceptions from process. Attend meetings as a representative of Quality, as designated by Quality Systems Manager. Work with R & D and Process Development team to ensure smooth and timely introduction of new products. Support regulatory requests for information e.g. for registrations Maintain knowledge and expertise of Medical Device Quality System regulations in order to provide specialist advice to the broader organisation. Deliver specific training for the Elstree facility staff as appropriate. Requirements Education Bachelor Degree or equivalent qualification in a scientific subject or technological subject. Additional training in GMP in pharmaceutical/QS and/or regulations/MEDDEV. Additional training in Computer System Validation and GAMP would be beneficial. Experience A minimum of three plus years experience required in the areas of GMP regulations that pertain to the medical devices/ pharma/ biologics. Working knowledge of drug or device regulations, including 21CFR Part 11 and 820, ISO 13485 and Medical Device Directives. Good working knowledge of Windows based applications such as M. Office and other computer systems (e.g. Trackwise). Ability to demonstrate strong organizational skills. Must demonstrate sound judgment and analytical skills to enable assessment of risk. Ability to analyse quality data, and to summarise in concise reports to communicate Quality System performance. Excellent communication skills � both written and oral. Personable and able to communicate with staff of all levels. Flexible approach to work and the tasks to be undertaken. Able to work cross-functionally. Able to work on a broad range of tasks simultaneously. Able to work with limited supervision. Good attention to detail. Previous experience of device/pharma companies in Quality Systems/Quality Assurance. Salary Package Basic Circa �27,000 Hours Monday to Friday 9am - 5.30pm Additional Benefits 25 days Holiday. Bonus. Pension Scheme. Medical Care. Childcare Vouchers
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