Description
We are looking for a
Validation Specialist (m/f)
Reference: -en
Start: asap
Duration: 12 MM
Place: in Neuchatel
Branch: Tabakverarbeitung
Your tasks:
- Participate in the implementation of validated computerized systems
- Take over validation activities for laboratory systems (GC, LC, and other analytical equipment)
- Develop validation plans based on available templates
- Develop user and functional requirements documentation, based on available templates, existing documentation for other systems, and information from SMEs
- Review vendor IQ-OQ documentation in collaboration with SMEs
- Develop performance qualification protocols and traceability matrices, based on templates, existing documentation for other systems, information from SMEs, and vendor IQ-OQ documentation
- Organize and follow execution of performance qualification tests
- Perform review of executed operational and performance qualification tests
- Develop validation report for laboratory systems, based on templates and generated validation documentation
- Manage relations with QA concerning validation activities (meetings with QA to discuss validation documentation, corrections stemming from QA review of the validation documentation)
- Manage change control documentation for validated systems and/or validated excel spreadsheets, including related testing
- Prepare validation documentation for archiving
- Perform reviews of validation status of validated systems (Performance Monitoring)
Your qualifications
- Bachelor's or Master's degree
- Knowledge in Quality Assurance, and especially in performing QA related tests
- Experience in validation of laboratory systems
- GxP experience
- Fluency in English
Skills:
- Qualification/validation specialist