Job Description
Descripción y detalle de las actividades
Ensure that validation process is executed and reported according to the Ontex guidelines to ensure an effective change management and a timely implementation.
- Configure validation protocols for each validation process.
- Ensure compliance with validation formats.
- Participate in the execution of the validation phases.
- Coordinate trials and ensure that all resources and roles are available and clear about their tasks.
- Perform the extraction of samples to be evaluated.
- Coordinate with laboratory heads the execution of tests and establish priorities.
- Lead the tests to ensure their success and report the results obtained.
- Participate in the analysis and verifications of the results obtained based on the samples performed.
- Create work instructions.
- Ensure that the processes comply with the required regulations (21CFR820, ISO 9001, ISO 13485).
Experiência y requisitos
- Bachelor's degree (univer...
Ensure that validation process is executed and reported according to the Ontex guidelines to ensure an effective change management and a timely implementation.
- Configure validation protocols for each validation process.
- Ensure compliance with validation formats.
- Participate in the execution of the validation phases.
- Coordinate trials and ensure that all resources and roles are available and clear about their tasks.
- Perform the extraction of samples to be evaluated.
- Coordinate with laboratory heads the execution of tests and establish priorities.
- Lead the tests to ensure their success and report the results obtained.
- Participate in the analysis and verifications of the results obtained based on the samples performed.
- Create work instructions.
- Ensure that the processes comply with the required regulations (21CFR820, ISO 9001, ISO 13485).
Experiência y requisitos
- Bachelor's degree (univer...
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