Quality & Microbiology Engineer

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.

Responsibilities:

• 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

Salary: Competitive

Location: Via della Stazione 2, Latina, Italia

Link for applications: https://www.smiths.com/job-search/job-details/?langCode=EN&nPostingTargetID=245329