Periode: 1 year
Our client is active in the food, life sciences, infrastructure, oil and gas and (petro) chemical markets by delivering:
- Support through consulting & engineering;
- delivering turnkey automated solutions;
- maintenance and support.
Responsible as technical reviewer/approver for lab equipment qualification, maintenance and retirement documentation, including calibration and testing protocols of external parties guaranteeing compliance quality policies. Provides technical expertise in investment projects for laboratory equipment. Responsible for establishing the annual maintenance program. Acts as SME and participates in global projects for Data Integrity activities related to computerized and non-computerized lab equipment.
- Knowledge and experience with quality and compliance guidelines, cGMPs;
- knowledge of industry guidance and respective regulations of Equipment Qualification and Maintenance, Validation, Quality Control, Quality (Management) Systems, Documentation, Change Controls;
- technical knowledge in testing techniques and lab equipment;
- technical Writing, Failure Mode & Effect Analysis (FMEA), and Lean Six Sigma;
- effective project management planning skills and ability to communicate on prioritization and bring others on the same page;
- computer literacy knowledge;
- ability to work under minimum supervision;
- strong focus on clients and end-user;
- hands on mentality;
- good communication skills and being pro-active and flexible;
- team work oriented;
- flawless Integrity Mindset (Data Integrity);
- excellent interpersonal and communication skills, oral and written (Dutch and English);
- at least 5 years of relevant experience preferably in pharmaceutical Quality Control and cGMP;
- furthermore, a sound knowledge of equipment design and use.