Job Description

Job Title : Computer Systems Validation (CSV) Consultant

We are seeking a Computer Systems Validation (CSV) Consultant to ensure compliance with GxP regulations and industry standards while supporting the validation and maintenance of global GxP IT systems. The ideal candidate will have a strong background in validation processes, regulatory compliance, and IT systems used in pharmaceutical and life sciences organizations.

• Interpret and enforce relevant GxP regulations and standards, providing guidance to ensure consistent application of requirements.
• Execute, manage, and document periodic reviews of global GxP IT systems.
• Review and provide coaching/oversight for non-GxP changes (Management of Change - MOC).
• Author and/or review GxP technical documents, including SOPs, Work Instructions, Risk Assessments, URS, CS, DS, IOQ, PQ/UAT, RTM, and validation reports.
• Support GxP projects for CSV systems, including new implementations, upgrades, and decommissioning activities.
• Provide quality review of validation documentation pre- and post-execution to ensure compliance with regulatory and company requirements.
• Collaborate with QA, IT, Operations, and other department personnel on assigned projects.
• Maintain and periodically update the global CSV inventory, as required.
• Perform other duties as assigned.

Qualifications & Experience:

• Bachelor's degree in Computer Science, Life Sciences, or a related field.
• Minimum of 5 years of professional experience in managing quality/compliance within a regulated Pharmaceutical or Life Sciences environment.
• Proficiency in Computer System Validation (CSV) within a GxP environment.
• Strong understanding of Quality Assurance (QA), GMPs, Health Authority Regulations, and Validation principles.
• In-depth knowledge of industry standards, including GMP, GAMP5, and regulatory requirements such as 21 CFR Part 11/210/211, ICH 8, ICH 9, and ICH 10.
• Familiarity with IT compliance SOPs, change control practices, and system risk assessments.
• Experience validating software applications such as SAP, Master Control (MC), and Compliance Wire (CW).
• Prior experience in managing Data Migration and Archiving projects.
• Proficiency in Microsoft Office applications, including Word, Excel, and PowerPoint.
• Excellent written and verbal communication skills.
• Ability to work independently and effectively communicate with technical and scientific personnel.

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