Computer Systems Validation

Confidential Company  •  Philadelphia, PA

Less than 5 years experience  •  Biotech/Pharma

Salary depends on experience
Posted on 08/08/17 by Peter Chen
Philadelphia, PA
Less than 5 years experience
Biotech/Pharma
Salary depends on experience
Posted on 08/08/17 by Peter Chen

Position: Computer Systems Validation

Location: Philadelphia, PA

Responsibilities:

  • Daily management of project activities and deliverables
  • Validation documentation creation and development including GxP Assessments, Validation Plans, Risk Assessments, Requirements/Design/Functional Specifications, IQ/OQ/PQ Protocols, Reports, Traceability Matrix, and Standard Operating Procedures
  • Test Execution and Deviation Management
  • Planning and scheduling of validation and Validation Lifecycle deliverables

Key Requirements:

  • Provide technical input to address validation deviations, provide technical assessments for change requests, identify qualification/validation requirements to ensure GMP compliance, assist in the design, analysis, execution and approval of IQ, OQ, PQ, PV, and UAT protocols and reports, and perform technical reviews of validation deliverables.
  • Create Technical Support Manuals for all new GMP systems. Develop, review and approve validation/qualification deliverables such as Validation Plans, Requirements Specifications, Configuration Specifications, Traceability Matrices, Summary Reports, Change Controls.
  • Effectively communicate the current status of all validation/qualification projects to management and to all affected stakeholders.
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