- 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%)
- 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.