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Senior Systems Validation Engineer - Medical

Eingestellt von Larson Group

Gesuchte Skills: Support, Engineer

Projektbeschreibung

The Role

Support for the activities associated with computer systems ensuring that all compliance issues and requirements of the Validation Policies and Procedures are addressed.

The Responsibilities:

To coordinate projects associated with the validation of computer systems [IT, Control and End user] as directed
To organize and lead Validation working parties associated with computer systems, providing a timely validation coordination service to Project Managers or identified Project Leaders
To provide support and input to quality manager/CSV lead to work towards a common computer systems validation process
To provide information on current regulatory and company standards that must be met to achieve and maintain compliance
Summary Reports and other documentation associated with validation of computer systems, as appropriate for each validation exercise
To ensure all validation activities and documents are authorised and appropriate compliance approval is gained

Skills/Knowledge:
Required:
Previous experience working in a regulated industry carrying out computer systems validation and/or testing activities
You should have two years working in an FDA regulated environment carrying out computer systems validation and/or testing activities
Knowledge of bespoke computer software and/or hardware specification, testing and documentation
Knowledge of the specification, testing and implementation of automated equipment with integrated and networked software applications
Software risk assessment and risk based testing methods
Experience in document authoring of validation deliverables.
You should be a proactive problem resolution
Experienced in Change Management
In depth knowledge of 21 CFR 820, 21 CFR part11, ISO 13485:2003 and European regulations associated with the medical device industry
In depth knowledge of GAMP 5 and SDLC process methodologies

Projektdetails

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Larson Group