Job Description
Responsibilities
- Lead and execute Computer System Validation (CSV) activities in accordance with GAMP 5 and regulatory requirements.
- Prepare, review, and maintain validation lifecycle documents including URS, FRS, Risk Assessments, IQ, OQ, PQ, Validation Plans, and Validation Reports.
- Manage change controls, deviations, CAPA, periodic reviews, and system lifecycle activities.
- Support qualification and validation of computerized systems, analytical instruments, and enterprise applications.
- Administer and support systems, including Chromeleon, Empower, LabX, LIMS, and other GxP applications.
- Manage IT/OT infrastructure, including servers, virtualization platforms, backups, archival solutions, and cybersecurity controls.
- Lead system implementation, upgrades, migrations, decommissioning, and digital transformation projects.
- Ensure compliance with 21 CFR Part 11, Data Integrity (ALCOA+), GMP, and applicab...