• Smiths Group – Laureati in Ingegneria, Scienze

Quality & Microbiology Engineer - Tempo indeterminato, Latina

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

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