Computer System Validation

Job Description

Validation Protocols: Plan, write, implement, and review Computer Systems Validation protocols.

Documentation: Author user requirements, validation plans, protocols, reports, and risk assessments.

Testing: Execute required tests in collaboration with production, QC departments, or external suppliers.

Periodic Reviews: Perform periodic reviews on existing validated systems to ensure they remain in a validated state throughout their lifecycle.

Audits: Support audits and update SOPs and work instructions as needed.

Design Reviews: Participate in design checks and reviews to guarantee required quality.

Project Management: Lead or participate in special projects or initiatives with cross-functional teams.

Primary Skills

Good understanding of guidelines like GAMP 5, USFDA 21 CFR Part 11, and Eudralex Annex 11