Job Description
Lead, develop, and execute comprehensive Computer System Validation (CSV) strategies, plans, and protocols (IQ/OQ/PQ) in compliance with FDA and global regulatory requirements.
Oversee validation activities for GxP-regulated computerized systems including , manufacturing equipment software, data integrity systems, and custom applications.
Ensure systems meet 21 CFR Part 820, 21 CFR Part 11, and ISO 13485 requirements for software validation and electronic records/electronic signatures.
Partner with cross-functional teams (Quality, IT, Engineering, R&D, Manufacturing) to ensure compliant system lifecycle management aligned with GAMP 5 guidelines.
Drive validation documentation creation, review, and approval, ensuring traceability and regulatory readiness.
Ensure systems used in support of GxP activities are validated and maintained appropriately in compliance with applicable FDA, EU and other internationa...