Description
Primary Tasks and Responsibilities:- 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.
- 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 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.
- Knowledge of MSA for mechanical industries, metrology and calibration for highly regulated environments
Start: ASAP
Region: Tessin OR Solothurn (Switzerland)
Duration: 6 months
If this outstanding opportunity sounds interesting for you, do not hesitate to contact me for more details or send me your CV.
For more information on this or other opportunities, please contact Silvio Fernandes at Real Staffing on or