Critères de l'offre
Métiers :
- Quality control Technician
Expérience min :
- 3 à 5 ans
Secteur :
- Security & Police
Compétences :
- English
- French
- Laboratory
- ISO
- GMP
Lieux :
- Le Vaud
Conditions :
- Temporary work
- Full Time
L'entreprise : Michael Page
Our client is a global science and technology leader in the medical devices sector
Description du poste
Work in a microbiological Quality Control laboratory (BSL-2) as per established procedures and work instructions in compliance with good manufacturing/laboratory practices (GMP/GLP)* Perform Bioburden analysis on raw materials and semi-finished products using a rapid alternative method (Scan RDI)
* Perform Bacterial Endotoxins Test on finished products using a rapid alternative method (LAL analysis with Charles River cartridges)
* Perform Environmental Monitoring of ISO7 / ISO8 cleanrooms (viables and non-viables sampling)
* Interpret inspection results in comparison with established specification and edit quality control reports
* Perform test result investigations for root cause and reports findings in case of non-conformities
* Write / update the Procedures and Work Instruction according to the needs of the evolution of the laboratory
* Participate to analytical method validation or equipment qualification
* Support other department such as Production, Manufacturing or R&D in different development projects
* Maintains a safe and healthy work environment by following standards and procedures.
* Analyse, evaluate, and interpret KPI's data and propose optimization of operations to improve these KPI's.
* Perform additional duties as required in the Quality Control laboratories
Description du profil
* CFC with professional maturity or equivalent diploma (such as BTS, DUT …)
* Minimum of 3 years of experience in Quality Control / Microbiology laboratory in Medical Devices or GMP environment
* Good experience in Microbiology process, methods
* Understanding of norms: ISO 11737 (part 1 and 3), ISO 14644, ANSIAAMI ST72
* Understanding of pharmacopoeia: USP<61>, USP<85>, USP<161>, EP 2.6.12, EP 2.6.14
* Ease of use Microsoft Office
* Analytical spirit, responsible, precise, rigorous and team player
* French language, English is a plusTechnician will work :
- in a BioSafety Laboratory Class II (BSL-2)
- in ISO7 / ISO8 cleanrooms