We are looking for a new colleague for our manufacturing partner
Clean Room Specialist
Feladatok
Implementation and provision of monitoring activities for clean rooms, technological media and products in accordance with the provisions of relevant guidelines
Provision of basic data for environmental monitoring reports
Participation in the monitoring and processing of deviations occurring in the scope of responsibility (CAPA)
Participation or lead investigations for OOS and deviations
Order nutrient media
Participation in monitoring of the implementation of the hygiene concept at the site
General laboratory organization and administration
Management the pest control process, keeping contact with external company
Responsible for the light intensity measurements, planning 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
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 ISO 14644 standard, GMP
