Computer System Validation Engineer

5 mesi fa

BOLOGNA, Italia Ntt Data Corporation A tempo pieno

For our fast-growing internal Life Sciences Team, we are looking for a Computer System Engineer involved in several stages of the Validation-cycle, from the upstream phase of capturing the customers' needs to the integration process as well as managing Quality Compliance of IT Systems relevant for GxP regulations.
Main responsibilities of the Role: • Partecipate in the definition of the validation strategy, in the specification and design of the integration and in the test execution carried out by the implementation phase.
• Ensure a technical interface with other professions particularly with the system, software, and product users.
• Interpret analysis linked to change requests.
• Set up Data Integrity Risk Assessment for all computerized and automated systems.
• Identify potential quality and compliance risks.
• Develop and review departmental documentation including training, SOP's, change controls ensuring GMP and applicable regulatory guidelines.
• Write and implement Validation documentation (Validation Plan, Validation Summary Report, Risk Assessment, Gap Analysis, IOQ, Periodic Review ….).
• Master degree in IT / Computer sciences / Industrial / Biotechnology / Chemistry or Pharmacy.
• A first experience in IT and CSV position would be appreciated.
• Familiar with GMP environment and V cycle.
• Ability to understand and extract necessary information from technical documents.
• Good teamwork and organizational skills.
Must have strong, organization and analytical skills.
• Facilitator, influencer and planner.
• Good oral and written communication skills in English.
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