CSV

Your Role

• Lead and support Computer Systems Validation (CSV) activities for GxP-regulated computerized systems throughout the System Development Life Cycle (SDLC).
• Ensure compliance with GxP, FDA 21 CFR Part 11, company SOPs, and Quality Management System (QMS) requirements.
• Review, assess, and approve validation deliverables, risk assessments, testing documentation, and change controls.
• Collaborate with Business, Quality Assurance, IT, and external vendors to ensure validated and compliant system implementations.

Your Profile

• Lead and support Computer System Validation (CSV) activities, including preparation and review of Validation Plans, protocols, reports, and compliance documentation across the system lifecycle.
• Conduct GxP compliance and risk assessments, define risk-based validation strategies, and ensure adherence to regulatory requirements such as FDA 21 CFR Part 11 and organizational quality standards.
• Review and oversee testing and qualification activities, including UAT/SIT protocols, test executions, defect management, qualification documentation, and validation evidence to ensure systems are fit for intended use.
• Manage validation documentation and traceability, including requirements reviews, Traceability Matrices, audit-ready records, and data migration/conversion validation activities.
• Support change control, stakeholder collaboration, and continuous improvement initiatives by assessing GxP impact, providing CSV subject matter expertise, and partnering with Quality, Business, IT, and vendors to ensure compliant system implementations.

What you will love about working here

• We recognize the significance of flexible work arrangements to provide support. Be it remote work, or flexible work hours, you will get an environment to maintain healthy work life balance.
• At the heart of our mission is your career growth. Our array of career growth programs and diverse professions are crafted to support you in exploring a world of opportunities.
• Equip yourself with valuable certifications in the latest technologies such as Generative AI.