Jelentkezés állásajánlatra
Clean Room Specialist Terület: Egyéb, VasKód: 1851
Feladatok
Environmental Monitoring:
- Implementation and provision of monitoring activities for clean rooms, technological media and products in accordance with the provisions of the relevant guidelines.(if necessary)
- Provision of basic data for environmental monitoring reports
- Participation in the monitoring and processing of deviations occurring in the scope of responsibility (initiation of CAPA for OOS & deviations in clean / controlled areas), as well as in supporting CAPA measures and investigations in cooperation with other departments.
- Participation or lead investigations for OOS and deviations.
- Order nutrient media (if necessary)
- Hygiene concept: Participation in monitoring of the implementation of the hygiene concept at the site
- Organization: General laboratory organization and administration (e.g. inventory management, orders, ensuring the calibration status of the devices used).
- Management the Pest Control process, keeping the contact with external company, review external reports and initiates CAPAs as per the internal process / limits
- Responsible for the Light intensity measurements, planing of external measures, address local actions if needed
- Participation in the qualification and validation processes of the infrastructure (clean room, controlled area, WFI, compressed air), responsible for the control and compliance with the required standards.
- Participation in the validation of microbiological process and test methods, preparation of reports.
- Preparation / support of URS of clean / controlled rooms
- Participation in the implementation / establishment and maintenance of the hygiene concept, its monitoring, dress code and clothing requirements and implementation of clean room check.
- Initial GMP training for new employees (if necessary) -
- Support assessments, projects and developments with knowledge / experience of GMP
- Follow GMP and GDP rules and make others keep to the rules. Support the employees with training and technical instruction in consultation with their supervisor.
- Support of process and product development through preparing risk analyzes related to bioburden, endotoxins and particle measurement, as well as during sterilization processes and procedures.
Elvárások
- BSc in natural science, microbiology, chemistry or biology
- At least 2 years of experience in microbiological laboratory and in clean room environment
- Experience in environmental monitoring
- Experience in bioburden test
- Knowledge of ISO 15378 / ISO 13485 and SO 14644 standard, GMP Good command of English
- Problem solving skills (OOS & deviation management)
Egyéb
Kiemelt állásajánlatok
- Épületüzemeltetési karbantartó
- Épületgépész mérnök
- Controller
- Clean Room Specialist
- Gyártósor beállító
