Computer System Validation

Job Title : Computer System Validation

Location : Remote

Project Overview

Validate and document software installed on laboratory instruments in alignment with EMA regulatory guidelines.

Transition the management of instrument software to PPD IT software management SOPs.

Capture and document current software requirements configurations and operational details.

Key Responsibilities

Collect and document business and technical requirements.

Develop and maintain software validation test cases.

Prepare detailed software specifications and related documentation.

Design infrastructure and data flow diagrams.

Conduct comprehensive risk assessments related to software and system configurations.

Required Skills

Strong technical writing and documentation skills.

Excellent verbal and written communication abilities.

High attention to detail and strong organizational skills.

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Key Skills

Python,SOC,Debugging,C / C++,FDA Regulations,Minitab,Technical Writing,GAMP,OS Kernels,Perl,cGMP,Manufacturing

Employment Type : Full Time

Experience : years

Vacancy : 1