Description

You will design, plan, and execute validation protocols for complex computer systems to ensure compliance with quality standards.

This role is remote.

Responsibilities

• Develop and review user, functional, and design requirement specifications.
• Create validation plans, process flow diagrams, test procedures, and test cases.
• Perform gap and risk analysis to develop effective remediation plans.
• Execute validation testing, including root cause analysis for identified problems.
• Review change tickets, approve changes, and provide detailed test result reports.

Required Skills

• Minimum 10 years of professional experience in computer systems validation.
• Expertise with MHRA, LVLIMS, LabwareLIMS, and GAMP.
• Strong working knowledge of cGMP, GDP, and GLP standards.
• Proficiency with TrackWise, IQ, and OQ protocols.
• Experience with RTM, HP ALM, and Quality Center.
• Two years of direct work experience with MHRA, LVLIMS, LabwareLIMS, GAMP, and cGMP.
• Two years of experience as a Systems Engineer, Network/Systems Administrator, or Network Architect.

Preferred Skills

• Master's degree in Computer Engineering, Network and Communications Management, Information Systems, or a related field.

Key Skills

Education

Any Graduate