
Computerized Systems Validation Professional
Há 6 dias
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.
- 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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Rio de Janeiro, Rio de Janeiro, Brasil beBeeValidation Tempo inteiro R$40.000 - R$80.000Computerized Systems Validation Analyst Job DescriptionJob Title: Computerized Systems Validation AnalystJob Summary:We are seeking a detail-oriented and proactive Computerized Systems Validation Analyst to join our Quality department. The ideal candidate will have a strong understanding of computerized systems validation principles and experience in...
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