Laboratory Specialist in Basel, Switzerland
Laboratory Specialist - Basel, Switzerland
Jocelyn Blackham is recruiting for a Laboratory Specialist to join a company in the drug discovery industry at their site based in Basel on a contract basis for 9 months with the possibility of extension.
The main purpose of the role will be to:
- Be accountable and responsible for development of functional laboratory test methods, implementation and validation for design control, incoming control testing and clinical release testing.
- Provide sound functional test method validation expertise and validation procedures.
- Define, procure and qualify equipment required for the test methods in partnership with suppliers.
- Create validation protocols and reports in compliance with applicable procedures, write test methods instructions and execute all qualification, validation Participate in design verification protocols, self-execute all tests accordingly.
- Create and maintain laboratory notebook and raw data compilation supporting any reports in compliance with data integrity requirements.
- Perform statistical analysis of all test data and report and actively participate in product failure analysis arising during testing.
- Effectively collaborate with quality and technical project functions and communicate tests results outcome and issues promptly.
- Ensure compliance with all local, state, federal, and company quality policies, procedures and practices, safety regulations, policies, and procedures.
Further responsibilities will include:
- Working in collaboration 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.
- Evaluate/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.
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- 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 Advanced statistical knowledge (e.g. use of minitab or the like, ability to use non normality transformation for statistical analysis...).
- Preferably knowledge of Medical Device ISO standard test method (ISO 11040, 11608...).
- Team orientation.
- Strong motivational fit.
- Previous experience in laboratory functional testing, laboratory equipment qualification and maintenance and statistical hands-on practices for medical devices or Combination product testing.
This is an excellent opportunity to join a rapidly growing pharmaceutical company.
For more information or to apply for this position, please contact Jocelyn Blackham on 0041 (0) 4172726793 or email jblackham@ckqls.ch. Please quote reference QLS44231 in all correspondence.