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Activities:

Under the supervision of the Global ICT Quality manager:

• Contribute to the definition of Quality guidelines for information systems in line with the company quality system and with specific industry regulation
• Contribute in issuing and maintaining up to date the (SOP) IS ICTQuality procedures and validation documents, monitoring the approval cycle
• Contribute to the definition of Computer System Validation guidelines
• May act as Validation manager for selected ICT Applications and in this role participate to the project of the implementation of new application as Validation Team leader
• Contribute to the definition of guidelines for the qualification of the technological infrastructure
• Contribute to the definition of the change management procedures in both application and infrastructure context and keep it up to date
• Provide training to IT staff (both HQ and local) on quality matters
• Support initiatives for improvement of operating procedures as follow up to internal audits or assessments
• Support Chiesi Quality Assurance team during inspections
• Support Quality Audits for GxP-relevant ICT Vendors
• May Support IT staff (both HQ and local) in the preparation of documentation prior to periodic inspections
• Provide operational support to IT staff (both HQ and local) on quality matters
• Provide operational support to IT staff (both HQ and local) in the assessment of risk associated with IT activities and projects (risk assessment), according to GICT risk assessment methodology
• Provide operational support in quality assurance matters in IT projects

Education: Technical-Scientific Degree (Information Technology, Mathematics, Engineering, Physics with specialization in IT or telecommunications)

Required experience: At least 2 years of experience as ICT Quality Specialist in pharma companies. Basic knowledge of Computer System Validation is required.

Technical skills:

Business knowledge, Pharmaceutical Legislations regulations (in particular FDA CFR21part11, EU ANNEX 11, MHRA Data Integrity), CSV Methodologies, GAMP (Good Authomated Manufacturing Practices), Policies/SOP making, basic Knowledge of the main components of the ICT Architecture, Project Management

Soft skills:

Teamwork, negotiation, flexibility, customer focus, result-orientation, quality focus and efficiency

Languages: English mandatory, Italian strongly recommended

Availability to travel: limited

Place of work: Parma

Contract type: Permanent