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Computerized System Validation Specialist

Main responsibilities:

  • Definition of required Qualification and Validation strategies for different Computerized Systems: Analytical Equipment, Manufacturing Equipment.
  • Review and approve Computerized System Development Life Cycle documentation, incident investigations and change controls related to Computerized Systems;
  • Participate in Engineering, or other Projects seeking for the best technical solution and cGMP compliance;
  • Guarantee a risk based approach for the Qualification & Validation activities;
  • Keep area up to date with guidelines on Computerized System Development Life Cycle and related technologies/tools.
  • Responsible and accountable for the development and delivery of a complete validation package: User Requirements Specification (URS), Validation Plan (VP), Installation/Operational/Performance Qualification Protocol (xQP), Installation Qualification (IQ), Functional Requirements Specification (FRS), Operational Qualification(OQ), Performance Qualification (PQ), Traceability Matrix (TM), Validation Summary Report (VSR), Configurations Specification (CS), Administration and User SOPs, SOPs or Forms and executing these protocols, if needed
  • Leads and supports CSV projects and related activities for IT supported systems. This involves understanding the business, determining business and system requirements, project planning, timeline, and collaborating with project team members in the development and delivery of validation deliverables including working with business users on developing test cases, performing dry-run, and updating test scripts.
  • Work collaboratively across functions with Quality, IT, Production, to plan, coordinate and execute computer system validation activities, and obtain fully approved documents.

Profile:

  • Academic degree in Engineering field such as Mechanical, Electrical or Chemical or equivalent degree in a scientific area;
  • 5 years of experience in Chemical / Pharmaceutical Industry environment and on computerized systems validation practices and regulatory requirements, including GAMP 5, Eudralex Annex 11 and 21 CFR part 11, will be a differentiation;
  • Knowledge of Data Integrity principles and Risk Management tools;
  • Analytical skills, proactive and creative personality;
  • Ability to multi-task, work independently, be self-directed and organized;
  • Comfortable working in a fast-paced and dynamic work environment;
  • Team working and multi-disciplinary approach ability;
  • Good communication skills;
  • Good English level (written and oral).

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