You have successfully logged out!
Menu
Jobs found
saved
add to favourites
Search News
Search Videos

Laboratory & QC Technician

Switzerland

  • Salary: Up to 680 CHF Per Day
  • Job type: Interim/Contract
  • Posted: 15/01/2019

Job description

General Function

 

·         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 Idorsia quality policies, procedures and practices, safety regulations, policies, and procedures.

 

Main Responsibilities

 

Technical Management

 

- Test Equipment:

 

·         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.

 

- Test Methods development and validation:

 

·         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.

·         Write test method instructions.

 

- Testing execution:

 

·         Manage Product storage and pre-conditioning required prior to testing

·         Perform all functional test internally and support testing with service Providers for sub-contracted tests.

·         Complete statistical analysis to acceptance criteria and write reports.

·         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.

 

- Required Skills

 

Leadership and Engagement

 

- Responsibility

 

·         Guarantee the quality of testing and accuracy of reported data.

·         Ensure method validation prior to testing execution.

·         Maintain equipment and tools calibrated and in a state of the art condition

·         Self-perform all internal tests.

 

- Leadership courage

 

·         Demonstrate and promote leadership courage by doing what is right. Instill confidence to team in the reliability of testing.

 

·         Technical and personal skills: Meticulous with particular attention to details for validation and testing.

 

 

- Desired Qualifications

 

·         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

·         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