Job Summary
A global professional services firm has a current position open for a Remote Biotechnology Information Technology Quality Assurance Leader.
Must be able to:
- Approve system life cycle deliverables and activities
- Represent IT Quality & Regulatory Compliance on cross-functional teams
- Consult on the authoring and conformance of validation-related deliverables
Skills and Requirements Include:
- Thorough knowledge of GxP and ERES (21 CFR Part 11 and Annex 11) regulations and guidelines
- Thorough knowledge of IT Controls methodologies, including GAMP5 and ITIL
- Knowledge of general software and database concepts
- Detailed knowledge of the general computerized system development life cycle
- Five or more years of experience in computerized system validation
- Knowledge of infrastructure technology and platforms