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Project Manager QC - Netherlands  

Sanquin (company)


Posted on : 08 March 2017

Project Description

Job description:Are you the QC Officer with several years of experience in project management?You will support a subset of different (inter)departmental projects by active contribution in project meetings, resource planning, milestone setting as representative for QC related to product development, validation and transfers. You will have an QC ambassador role in project teams and strong analytical and negotiating skills. Duties and responsibilitiesProject planning and defining scope related to different (inter) departmental SPP projects;Activity planning, resource planning and sequencing;Time and cost estimating and developing schedules and a budget;Review and awareness of validation protocols and reports according Good documentation and GMP guidelines;Riks analysis (FMEA) and strategic influencing;Monitoring and Reporting Progress;Business Partnering/Stakeholder Management;Controlling quality;First point of contact for various departments;Where you will work:Sanquin Plasma Products aims to offer a wide range of high quality blood products (or biotechnical variations). These products are basically produced in our own production facility according 'state of the art' technology, prepared from blood plasma which meets the highest security standards. In addition, these products are also produced for external parties. In this role Sanquin operates as the CMO. At the Quality Control Department analyses are performed on one or more incoming-, in-process- and finished blood products. The department QC Projects & Stability is responsible for the introduction and validation of analytical-chemical and microbiological methods (development and verification / validation) for existing products and for new products (also for external parties where Sanquin operates as CMO). Furthermore the department supports on troubleshooting to ad hoc problems and events created in the laboratory, remediation activities related to compliance issues in methods and procedures/processes and validation of existing and new laboratory equipmentWe are looking for:Preferably HBO analytical chemistry or bio-chemistry degree;Several years Project Management experience in a Pharmaceutical environment;Have experience with laboratory analytical or microbiological method validation and/or method transfers;Experienced with TrackWise, MS-Project and SharePoint;;Familiar with GMP, GAMP5, Pharmacopeia and ICH validation guidelines;Good communicative skills, as well in Dutch as English;Meticulous and sense of safety and hygi

Locations

Amsterdam Netherlands

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