- Possess system quality and compliance knowledge of Computer System GxP regulations (21CFR Part 11, Annex 11 & ISPE GAMP guidelines).
- The role will be responsible for performing Gap Assessment on existing computerized systems.
- Experience with hands-on authoring/review/approval of computer system validation deliverables. These may include: Validation Plan, Risk Assessments, Design Specification, Configuration Specification, Functional Specification, IQ, OQ, & PQ Protocols, Traceability Matrix and validation Summary Reports.
- Comfort authoring, dry running, & review & approval of IQ, OQ and PQ test scripts.
- Minimum 5 years of CSV Experience in the Pharma Domain.
- Demonstrates strong organizational, verbal, written and presentation skills.
- Additional experience with Equipment, Facility and Utility Validation is a plus.