Laboratory & QC Technician
Our client, an innovative and dynamic bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, committed into delivering products on the market over the next 5 years, is looking a Laboratory & QC Technician for 9 months contract based in the Basel area.
The ideal candidate should have at least 7 years of experience in laboratory functional testing, laboratory equipment qualification and maintenance and statistical hands-on practices for medical devices or combination product testing.
- Collaborate with the Product technical experts, quality engineering, and suppliers (where appropriate), define equipment required for each test methods, procure and qualify equipment including protocols and reports writing;
- Create the equipment calibration and maintenance plan;
- Elaborate/Develop test methods required by product functions to test;
- Procure and control test method fixture to requirement;
- Create test method validation protocol and acceptance criteria (variable data or attributes), procure tests parts, execute test method validation and write associated report;
- Transfer method from/with suppliers including equivalency tests method statistical criteria for qualification and validation and execute transfer,
- Manage Product storage and pre-conditioning required prior to testing and perform all functional test internally and support testing with service Providers for sub-contracted tests;
- Create and Maintain a laboratory notebook and ensure raw data integrity and accuracy using a four-eyes principle. Analyze any test failure, demonstrating if it is test method related or product related. Where product related, collaborate pro-actively with technical expert for investigations and resolution;
- Guarantee the quality of testing and accuracy of reported data and ensure method validation prior to testing execution.
Qualifications and Experience:
- Minimum 7 years of experience in laboratory functional testing, laboratory equipment qualification and maintenance and statistical hands-on practices for medical devices or Combination product testing;
- Demonstrated functional test validation expertise for both variable and attribute test methods;
- Demonstrated laboratory equipment and control knowledge and compliance to GLP;
- Advanced skills in method validation and statistical knowledge(use of Minitab);
- Preferably knowledge of Medical Device ISO standard test method;
- Demonstrate and promote leadership courage by doing what is right. Instill confidence to team in the reliability of testing;
- Meticulous with particular attention to details for validation and testing;
- Relevant working/residency permit or Swiss/EU-Citizenship required.