|Title: Veeva Vault / QMS Validation Specialist|
Type of role: 12+ months contract
Location: Emeryville, CA
- Must have experience validating Veeva Vault QMS system in a Pharmaceutical / Biotech environment.
- Work independently on and successfully solve problems and complete/qualify a system within given constraint of scope, time and schedule.
- Working knowledge and an in depth understanding of GxP systems validation processes and Title 21 CFR Part 11 of the Code of Federal Regulations.
- Experience in Project execution within systems validation
- Extensive knowledge of the development of protocols for the validation of complex computer systems (e.g., multiple GAMP classes of systems); Protocol development will include ability to develop Installation, Operational and Performance qualification documents.
- Experience with all pertinent industry best practices (e.g., ISPE GAMP) including development and execution of all applicable system life cycle deliverables (e.g., URS, SRS, FRS, DDS, RTM, Unit, Integration, User Acceptance testing, Validation Planning, IQ, OQ, PQ, Final Validation Summary Report).
- Demonstrate expertise in system qualification and regulatory compliance and internal requirements employing regulatory guidance and industry standards.
- Ability to plan and manage own work
- Must have excellent verbal communication and technical writing skills.