IndirizzoDescrizione del lavoro:
A family-owned company, bioM?rieux has grown to become a world leader in the field of in vitro diagnostics. For 60 years and across the world, we have imagined and developed innovative diagnostics solutions to improve public health. Today, our teams are spread across 45 countries and serve 160 countries with the support of a large distribution network.
Come and join a family-owned global company with a long-term vision, and a human-centered culture.
As Validation Specialist, you will be part of a digital transformation project. Your main mission will be to validate non product software in accordance with our Quality Management System and guidance. You will join a Team of 12 employee and directly report to the site Quality Manager.
What will be your missions at bioM?rieux?
* Manage and follow automated systems and processes according to Site Validation Master Plan. Support to system owners for establishing a validation plan and cooperation for the release of IQ, OQ, PQ test protocols. Help system owners on performing the tests according to the IQ, OQ, PQ protocols and redaction of final validation summary reports.
* Help to manage the inventory of GxP Data Types according to bioM?rieux Italia implementation plan. Purpose of the activity is to assist each process owner to perform the Data Integrity inventory for data type:
* perform the inventory by Data Type, determine the Risk Level, identify the data record media type (paper, electronic, combination of paper/electronic) and other information requested.
* complete the Data Integrity Assessment by data type
* Provide support at the Digitalization Development team to ensure proper guidance on validation activities linked to developed applications; perform the GxP and 21CFR pat 11 assessment; contribute to the development of protocols
* Execute assigned validation projects, with guidance and support from project validation lead/manager. Depending on your level of seniority, employ robust validation principles and practices assuring project requirements, risk mitigation, project timelines and compliance to regulatory requirements and internal procedures are achieved.
* Assure validation documentation is generated, reviewed and approved in accordance with documented procedures.
* Support Change Control processes in support of Computer Software changes, re-validation and re-qualification initiatives.
* Participate in project planning activities in support of validation tasks and communicates validation status. As necessary, you will raise issues and concerns during project lifecycle.
Who are you?
* MSc in Industrial Engineering, Quality or Information technology with a strong interest for non product software validation.
* Strong knowledge in Quality Management System.
* Ideally, a first experience in a Good Manufacturing Practice (GMP) environment.
* Good analytical skills and system thinking attitude.
* Proactive and self-starter
* Knowledge of Domestic and International Regulations and Industry Standards (e.g. ISO, QSR, UL, CSA, VDE, EU, GAMP, FDA, etc.).
* Ability to use common software tools and to learn and apply new validation methodologies as needed on assigned projects and tasks.
* Good communication skills and writing skills.
* You are fluent in English and ideally, you have some basics knowledge of Italian.
bioM?rieux welcomes applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.
Job ID: 46561
