Pubblicato il 17/10/2019
Tipo di Laurea: Ingegneria, Chimica, Biologia, Biotecnologie o similari
At Smiths Medical in Latina, we are looking to hire a Quality & Microbiology Engineer on permanent basis. Under minimal supervision the incumbent will perform both Quality and Microbiology related activities.
- Management of Quality System documentation in accordance with ISO 13485 standards
- Sets up equipment for tests.
- Integrates continuous improvement concepts and techniques into all aspects of the job.
- Definition and review of procedures, SOPs and forms to support business processes
- Management of non-conformities and internal or supplier deviations
- Management of corrective and preventive actions (CAPA)
- Management of Product Change Notification (PCN)
- Support during internal or external audits (from Customers and Competent Authorities / Certification Body)
- Cover microbiology activities as : environmental monitoring and facilities periodic qualification, air sampling, particulate monitoring, environmental bioburden and other periodical microbiological activities planned in classified areas
- To support the Quality Dept in preparing the quality procedures (Execution Plans, Interface, Coordination procedures, etc.).
- To collaborate with manufactory plants in monitoring the product quality.
- To assess the suitability of suppliers and subcontractors and to review their quality plans and quality activities, ensuring they work in compliance with project quality requirements.
- To plan and perform quality training activities within the project team.
- To plan and perform quality audits to project processes/activities, manufactory plants, suppliers and subcontractors.
- To follow-up client quality audits, non-conformities, complaints, etc.
Technical Knowledge, Skills and Abilities:
- Technical Degree (Engineering, Chemistry, Biology, Biomedical, Life Sciences, or related field)
- Knowledge of ISO 9000 series standards and IS0 13485-GMP and micro environmental monitoring
- Strong experience in GMP environment
- Strong technical writing skills to develop GMP documents
- Excellent communication skills
- Experience with process validation area is a must
- Knowledge of GMPs
- Experience developing staff regarding teamwork and procedures to ensure GMP compliance
- Fluent in both Italian and English
Type of contract: Permanent
Location: Via della Stazione 2, Latina, Italia
Link for applications: https://www.smiths.com/job-search/job-details/?langCode=EN&nPostingTargetID=245329