ICT TechOps Quality Specialist -… at Menarini Group · Florence

Overview

The Global Application and Processes direction, ICT TechOps function is looking for a Specialist to be allocated in the area Quality in particular to support Quality Control processes (LIMS and LES areas). The resource will be allocated supporting strategic programs of the Group, in the related systems competence center and will manage autonomously as Project manager the projects such as new systems implementations and upgrades

Main Activities & Responsibilities

The resource will be responsible for activity of functional requirements analysis, project management, processes and integrations design and implementation in the LIMS (Laboratory Information Management System) and LES (Laboratory Execution System) areas. It will be required to support or execute unit and integration tests (C&Q tests), technical or qualification documentation writing, end-user support. It will be the system administrator of Global Systems and will be managing and supporting the systems AMS.

It will manage projects regarding complex GxP systems in Quality Control both based on off-the-shelf systems or developed using company frameworks. It will manage vendors and external resources and will collaborate with Quality Assurance and other business departments to ensure system lifecycle during implementation and maintenance phases. The resource will manage development projects for improvements and maintenance in the Quality Control area.

The Resource will collaborate with Quality Unit Manager to determine and manage the area budget and projects pipelines.

Job Requirements

Mandatory Requirements:

• Master degree in engineering, computer science or other science areas
• Good Knowledge of integrated information systems for Quality Control area
• Proven experience in Project Management for Global software implementation
• At least 3 years of experience in IT Systems and QC Laboratory systems administration
• At least 3 years in CSV testing activities
• Good knowledge of GxP requirements with a focus on Data Integrity, GAMP 5 and other relevant computerized-systems management regulations such as EU Annex 11 and CFR 21 part 11.
• Good problem-solving, team working, self-governance and focus on results capabilities
• Available for business trips in Italy and abroad
• Excellent knowledge of English both written and oral

Strongly preferred skills:

• Good knowledge of Labware and Empower

Additional preferred skills:

• Good knowledge of basic infrastructure and integration (e.g SAP-PO; BOOMI) tools
• Knowledge of SQL, Crystal Report programming
• Training or certification as Project Manager
• Basic knowledge of AI tools (embedded or standalone) architecture and capabilities