Job Description
- Plan, write, implement, and review Computer Systems Validation protocols.
- Author user requirements, validation plans, protocols, and reports.
- Execute required tests in collaboration with relevant departments.
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
