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Computer Systems Validation (CSV) Engineer

salary Salary :

$4,500 - 6,500 monthly

icon briefcase Job Type : Full Time

Number of Applicants

 : 

000+

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Job Description - Computer Systems Validation (CSV) Engineer

Key Responsibilities

  • Work with Engineers to develop Computer Validation Strategy, plans, protocols, reports, risk assessment, requirement traceability matrix etc for any new or change induced validation system / activities.
  • Schedule, organize and coordinate at detailed site level, validation activities with cross functional groups
  • Assist in raising Change Control to update Automation System Life cycle documentation, SOPs, Risk Assessment, Requirement Traceability Matrix etc.
  • Review and approve of validation protocols, reports and deliverables for the specialized validation area
  • Define requirements for validation activities and ensure regulatory compliance based on Risk Assessment
  • Creation and/or review of validation lifecycle documents: User Requirement Specification, Functional Specification, Risk Assessments, Validation Protocols (IQ/OQ/PQ/CPV) and Reports, Study Protocols and Reports, Requirement Traceability Matrix, CFR Part 11 assessment and validation submission dossier
  • Review and check documentation for GMP compliance
  • Collaboration and or Creation of Validation summaries

Requirements

  • Degree in Engineering/Pharmaceutical/Computer Science or related studies
  • At least 4 years of experience in a CSV role within the pharmaceutical industry is a must.
  • Good fundamental technical knowledge of automation system such as Siemens PCS7, DeltaV or IT system to assist automation engineers in developing life cycle documentation.
  • Knowledgeable in GAMP5, ANSI/ISA-88 and 21 CFR PART 11 requirements
Original job Computer Systems Validation (CSV) Engineer posted on GrabJobs ©. To flag any issues with this job please use the Report Job button on GrabJobs.
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About the Company

PM ASIA PROJECT SERVICES PTE. LTD.

PM ASIA PROJECT SERVICES PTE. LTD.

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