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Project Manager QC - Netherlands  

Company managed [?] Still accepting applications
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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 responsibilities
  • Project 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:
  • Our company 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. 
  •  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 company 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 equipment

We 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 hygiëne;
  • Service-oriented attitude, have perseverance and persuasion;
  • Stress resistant, flexible and goal-oriented;;
  • Willing to travel (5%)

We offer:
  • Training and development opportunities;
  • The end of year bonus will amount to 8,33% of the annual salary;
  • 201 holiday hours per calendar year;
  • Contribution to the travel expenses;
  • Various discount agreements for private Insurance.