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Quality Officer

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Quality Officer

Role description As a Quality Officer you have an interesting variety of tasks to support the Quality Manager. Primary Responsibilities and Tasks Prepare release of final product for Medical Devices & release of final products for non-Medical Devices Release article cards & bill of material (BOM) in our ERP system Release of specific raw materials, primary and secondary packaging materials Support in dummy recall Support in supplier management (batch record reviews, supplier qualification and evaluation etc.) Administrative support of the Quality Manager for the general supplier and product management (reports of recurrent meetings, follow up on action items, CAPA’s, deviations etc.) Support in change control, process validation & pilot batch production (admin, prep reports, follow up with CMO, …) Approval of ’02 PRFI’s & review of underlying documents Support in creation of manufacturing instructions, flowcharts, 08- and 10 PRFI’s, test methods, specifications Perform supplier audits Support Quality Manager in stability management Calibration & verification ofspecific lab equipment at Oystershell laboratory Registration, investigation and reporting of non-recurrent complaints Invoice review and approval, initiation of purchase orders Support in waste and retain sample management You are the back-up for the Quality Assistant (excluded Doc Admin) Job requirements Education & experience Bachelor’s Degree (preferably in Sciences: Pharmaceutical Sciences, Biomedical sciences, Bioengineering) or equal through experience Proven experience in a role within a quality department or in a lab You have a pharmaceutical or chemical background. Technical skills Excellent knowledge of Dutch and English You have knowledge of ISO standards; good knowledge of ISO13485 is a plus. You have experience with root cause analysis & CAPA, complaint handling, stability testing, change control / MOC and deviations. Microsoft Outlook, Word and Excel have no secrets for you. Affinity with ERP/DMS packages is required. Competencies & expected professional attitude You have a mature, positive personality and love challenges. You are passionate and have strong organizational and administrative skills. You work in an accurate and structured way. You have a ‘can do’ & hands-on mentality. You respect deadlines and work efficiently. Above all, you are a team player. Through your excellent communication skills, you ensure optimal cooperation within the company with all departments. It is our expectation that you live up to our quality standards as described in the quality policy. We expect you to take the necessary actions to comply with the quality objectives. Are you ready for the next step in your career? Send your CV and motivation letter to hr@oystershell.be. Response and confidentiality are guaranteed.
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