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QA Expert in Qualification
Il y a 4 mois
This innovative biotech working on atypical products is looking for a QA Expert in Validation & Qualification to help them reach their next milestones.
In order to fulfill his/her role, the QA Expert in qualification/validation:
- Implements the equipment, HVAC qualification and CSV part of the QMS procedures
- Takes part in writing, reviewing of the QMS documents
- Writes, reviews the design documentations, the validation plans, the qualification/validation protocols and reports and the validation summary reports
- Ensure QA activities on quality system
- Implements and validates the electronic management systems
- Validates the softwares associated to analytical equipment, process automation
- Review the specific CSV documentation (audit trail)
- Support the team during internal and external audits
- Ensures a timely follow-up of QA action
- Provides training to the team on equipment, HVAC qualifications & computerized system validation procedures
- Follow up regulatory updates regarding equipment, and CSV topics
- Ensure data integrity compliance of computerized systems
**Skills**:
- At least 5 years of relevant experience
- Fluent in English, speaking and writing
- Good writing skills in English
