Description of the Quality Control unit:
- The Quality Control (QC) unit is part of the Quality Assurance & Regulatory Affairs department. The QC unit is responsible for the development and qualification of analytical methods, analysis of intermediate and final product samples and samples from process development
- In addition the QC unit is responsible for the management of outsourced testing and the execution of stability studies
- Within QC there is a vacancy for an experienced QC technician
- The QC technician reports to the Director of QA & RA.
- Execution of analyses (microbiology, HPLC / UPLC (SEC, Affinity, RP), spectrophotometry, electrophoresis, pH, conductivity, ELISA) on samples from production
- Development of analytical methods (including generation of work plans, execution of the work plan and generation of a development report)
- Validation of analytical methods according to a protocol including the generation of a validation report
- Correct documentation of test results according to documented instructions
- Generation and revision of Standard Operating Procedures (SOP’s)
- Perform and report stability studies
- Calibration of analytical equipment
- Review of analytical data
- Participate in projects, support of QA.
- You operate at BSc. Level (microbiology or biochemistry) and have a proven track record working in a laboratory
- Experience with microbiological assays.
- You know how to operate with quality standards as cGLP, GMP or ISO9000/9001
- You can work in a team as well as independently
- You are prepared to work a few days per year in a late shift (e.g. 12:00 – 20:30 hrs.)
- You master the English language (both orally and in writing).
Preferred Qualifications (nice to have):
- You have at least 3 years of relevant work experience
- You have experience with development and validation of analytical methods
- Dutch language is preferred but not essential
Bron : Thermo Fisher Scientific Inc