Computerized Systems Validation Professional

Há 6 dias


Rio de Janeiro, Rio de Janeiro, Brasil beBeevalidation Tempo inteiro R$948.400 - R$1.116.000
Computerized Systems Validation Specialist

We are seeking a proactive and detail-oriented Computerized Systems Validation Specialist to join our Quality department.

This role is responsible for ensuring compliance with regulatory guidelines by validating computerized systems and supporting continuous improvement initiatives.

  • Key Responsibilities:
  • Validate both legacy and new computerized systems.
  • Maintain and update the Computerized Systems Validation Master Plan and Inventory.
  • Prepare full lifecycle documentation: planning, risk analysis, functional/technical specifications, qualification protocols, final reports, and periodic reviews.
  • Support and improve BPx system areas.
  • Evaluate change requests and CAPAs related to system validation.
  • Assist in deviation investigations and CAPA processes.
  • Conduct audits to ensure validated status of embedded BPx systems.
  • Participate in inspections and audits related to computerized systems validation.
  • Support Federal Revenue audits to maintain OEA certification.
  • Presentation of EHS topics monthly in DDS meetings and engagement in global projects.
Requirements
  • Education: Degree in Pharmacy, Systems Analysis, Chemistry, or Chemical Engineering.
  • Experience: At least 2 years of experience in Computerized Systems Validation.
  • Skills: Advanced knowledge in computerized systems validation.
  • Software: Proficiency in Microsoft Office (Word, Excel, Visio, PowerPoint).
  • Desirable: Knowledge of PLC, HMI, basic programming, IT infrastructure, application servers, and databases.
  • Soft Skills: Self-confidence, teamwork, organization, focus, interpersonal skills, and proactivity.


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