Beschreibung
Product Quality Engineer - GMP/Validation/Pharma - Lucerne 100%
Project/Role:
For one of our clients we are looking for a Product Quality Engineer/Validation Specialist with experience in medical technology or another regulated area (pharmaceuticals) to support one of our global IT projects. The role is contract position for 11 months (with strong possibility of extension) close to Lucerne, Switzerland.
Main Tasks:
- Preparation of the test concept and test planning during consumables product care activities.
- Includes the development of testing and measurement methods including their validation
- Review of the entire validation documentation of the supplier and documentation of the results from the external qualification and/or validation according to Roche requirements
- Review and collaboration in the preparation of process risk analyses
- Review of the entire validation documentation of the periodic review of valid processes
- Review of the entire validation documentation of the external qualification and/or validation according to Roche requirements
- Review of the entire validation documentation of the periodic review of valid processes
- Review of the entire validation documentation of the external qualification and/or validation according to Roche requirements
- Review and collaboration in the preparation of process risk analyses
- Review of the entire validation documentation of the periodic review of valid processes
- Review of the validation documentation of the external qualification and/or validation according to Roche requirements
- Review of the process risk analysis
- Review of the external validation documentation of the supplier.
- Project management of allocated work packages from product care projects
- Support and coordination of validation projects in close cooperation with the disciplines involved
- Ensuring GMP-compliant documentation - Storage and archiving of documentation
- Special tasks and special projects as agreed with the superior
Skills/Requirements:
- Basic understanding of injection moulding and machine technology
- Basic knowledge of quality testing and quality management
- Experience in measurement technology, in particular for requirements regarding the suitability of measuring equipment and methods
- Professional experience in medical technology or another regulated area (pharmaceuticals)
- Knowledge of ISO 13485 - Knowledge of GMP and compliance
- Basic knowledge of risk management
- Good MS Office skills
Education:
- Bachelor of Science with a focus on technology, mechanical engineering, industrial design, polymer technology, automation or similar.
Language:
- German - Proficient
- English - Good
Reference No.: 917679NC
Role: Product Quality Engineer
Industry: Pharma
Location: Luzern und Region
Workload: 100%
Start: ASAP
Duration: Till 30.09.2019
Should you find yourself suitable for this position then please send us your complete CV.
Contact us for further information regarding our company, our positions or our attractive payroll-only-program.
About us:
ITech Consult is a certified ISO 9001:2008 Swiss company with offices also located in Germany and Ireland.
ITech Consult is specialised in delivering IT candidates for contract work. We were founded in 1997 by IT professionals; hence we well understand what it means to be professionally supported in your search for a new project and being employed.