Quality Specialist Project

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7b0d56

Our diverse product portfolio, specialising in fluid delivery, is designed with the main objective of improving the patient's quality of life.

The Quality

Specialist performs both Quality System and Quality Assurance activities according to ISO 13485.

Quality Assurance: She/he will be responsible for controlling the batch record documentation and executing the batch release on the ERP according to shipment planning. Supervise the request for additional analysis for sterilization and bioburden control and keep update the record of results Manage non-conformity and deviations through the investigation process and documentation analysis, assessing the risk and material disposition in collaboration with DQA and Engineering. Manage and ensure the application of procedures in place for contamination control of clean room and facility (clean room validation, monthly analysis of clean room parameters, cleaning plan application, pest control, training staff on entry/exit procedure, etc..).

Ensure the execution of the cleaning plan, pest control, and clean room validations.



Support on New Product Development Programs Particularly Design Transfers / Participate in quality improvement initiatives and cross-functional projects. Manage supplier quality activities and qualification processes.

Quality Management System: Maintain and improve the QMS in compliance with ISO 13485. Ensure that the processes required for the Quality Management System are established, implemented and maintained up to date.

Manage

Training process Degree in technical or scientific fields (pharmacy, biology, engineering). Previous experience of 2-3 years in quality assurance. Good knowledge of the main sterilization technologies with particular reference to sterilization with ETO. Good knowledge of microbiology and related sterility tests, bioburden, etc. In-depth knowledge of standards and standards applicable to the type of activity of the organization (MDD 93/42/EEC, MDR, EN ISO 13485, 21 CFR 820, GMP).

Experience in quality systems audit according to EN ISO 13485, 21 CFR 820, GMP. Ability to interface with the different departments of the organization. Knowledge of the most popular Computer systems. Excellent written and spoken Italian and English. #

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7b0d56