Description
Primary Tasks and Responsibilities:• Serve as the technical expert for the Test Method Validation process to ensure compliance
• Continuous Learning/Managing Risk
• Resolving technical operational problems in areas of expertise
• Suggest innovative and continuous improvement ideas within the Test Method Validation processes
• Influence and persuade others to make technical and process improvements.
• Create the Test Method Validation Master List.
• Write and review Validation Master Plans, Test Method Procedures, Protocols, Summary Reports and other documentation associated with Test Method Validations, as appropriate for each validation exercise.
• Serve as a member of a team of experts to identify the worst cases and establish a bracketing approach to remediate the Test Method Validations in place.
• Ensure all validation activities and documents are authorized and appropriate compliance approval is gained.
• Inform Management of significant quality issues in a manner commensurate with the potential impact of the issue on public health, employee health & safety, company operations, and/or the environment
Profile:
• Expert knowledge of Functional and Physical Test Method Validation.
• Manufacturing and Medical Device production process knowledge.
• In depth knowledge of 21 CFR 820, 21 CFR 11 and European regulations associated with the medical device industry (ISO 13485, ISO 9001 and technical norms related to validation), knowledge of GHTF.
• High understanding of GMP, GDP, GXP, Compliance, Validation Practices including the system development life cycle and Regulatory expectations.
• Working experience of validation and test method validations for use in a FDA regulated environment.
• Knowledge of process statistics (desirable Six Sigma Green Belt or higher certification)
• Knowledge of MSA for mechanical industries, metrology and calibration for highly regulated environments
Desirable:
- A degree in an appropriate discipline (e.g. Engineering, life-science, natural sciences) with a broad technical/educational skill base and substantial related experience
- Minimum of 2 - 5 years working in a regulated industry including 2 of which has been spent carrying out validations.
- Minitab knowledge is preferred
- Fluent German and English (written and spoken)
Focus:
-Practical Technical Validation
-Test Method Know how
-21 CFR 11
-Measurement System Analysis
Someone with team spirit, but very independently working/delivering attitude.