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Opis:

QA Specialist - Medical Devices Nr ref.: /JOBS.pl On behalf of our client, a global pharmaceutical company, we are currently recruiting for a QA Specialist for medical devices. Purpose: Ensures relevant regulatory information is available for product release Liaising with local and external affiliates to ensure regulatory compliance at manufacturing sites is maintained. Initiating and managing regulatory compliance remediation activities to ensure registered information complies with manufacturing site practices Participation in process improvement projects providing direct QA support throughout project execution Coordinate customer complaint system Completion of Deviations and Change Control in partnership with the other departments Managing Project, where required Monitoring trends in product quality parameters, Deviations and Change Control developing proactive recommendations to maintain company's performance under control Duties: Deviation/Change Control/Regulatory Compliance Ensures relevant regulatory information is available for product release Liaising with local and external affiliates to ensure regulatory compliance at manufacturing sites is maintained. Initiating and managing regulatory compliance remediation activities to ensure registered information complies with manufacturing site practices Initiates, authors, and possibly assist in approvals of deviations ensuring they contain the essential elements necessary to assure continuous product and process compliance and improvement in company performance. Assures completeness in terms of root cause, action taken, and preventative measures. Authors, tracks, and/or ensures timely closure of commitments (Regulatory Agency, investigation, audit, PQR, and other) company is responsible for. Provides oversight for the analysis of Customer Complaints and reporting for company and assures timely completion. Authors and ensures timely completion of Change Controls, Action Requests, and Change Control related commitments Carries out SME role on QA aspects of process owned by company. Participates in SOP preparation as such. Facilitates the management of the PQR process as required Monitoring Trends Monitors trends in quality parameters presenting recommendations to the management to maintain process under control and/or to further improve the process Utilizes systems (e.g., Trackwise,) and applies tools (i.e., SPC, Six Sigma, DMAIC) to prepare trend reports. Participation in Process Improvements Applies cGMP knowledge to recommend action plans to the teams supporting process improvements Provides data on quality parameters, Deviations and Change Control trends to support continuous improvement. Links with the quality management to facilitate the implementation of Group wide initiatives. Managing Project, where required Adherence to Company Health & Safety procedures Participate in training programmes Requirements -Min 2 years experience in a similar QA role within medical devices, or related sector -Relevant Degree or equivalent qualification in science To apply for this role please send CV to or call Linda on 00353 1 for more details. Kontakt: Aplikuj teraz Ogłoszenie pochodzi z serwisu Jobs.pl .

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