Computer Systems Quality Assurance

Job Description :

We are seeking an experienced Computer Systems Quality Assurance (CSQA) Specialist to support the expansion of our clients ERP systems and associated applications across new and existing manufacturing sites. The CSQA will provide quality oversight to ensure all systems are developed, validated, and maintained in compliance with corporate Computer System Validation (CSV) standards and regulatory guidelines.

Responsibilities :

• Provide quality oversight for IT systems implementation, enhancements, and maintenance.
• Ensure compliance with CSV, GxP, and 21 CFR Part 11 requirements.
• Review and approve validation deliverables including requirements, test scripts, deviations, and reports.
• Collaborate with cross-functional IT, QA, and business teams to ensure proper validation and documentation.
• Support audits and inspections by providing required documentation and responses.
• Utilize tools such as Veeva Quality Docs, ServiceNow, JIRA, and Client ALM to manage validation and compliance activities.
• Contribute to continuous improvement of IT Quality and CSV processes.

Requirements :