CSV Validation Engineer
Cary, NC
Requirements
Define validation Strategy for computerized systems and platforms utilized in GxP Space
Experience with Veeva Vault Systems
Cary, NC
Requirements
Define validation Strategy for computerized systems and platforms utilized in GxP Space
- Create Validation deliverables such as Validation Plan, Test Protocols, Traceability matrix and execution of protocols
- Participate in user review meetings, discussions with Quality Assurance and Compliance groups
- Participate/conduct Risk Assessments
- Develop and maintain policies and procedures
- Effectively communicate the validation activities and deliverables to the project team, customer stake holders and global team within Zifo
- Act as a liaison between Zifo remote teams and customers in US & Canada
- Participate in internal initiatives around Computer Systems Validation
- Bachelor or Master's degree in Lifesciences or Computer Sciences
- 5+ years' experience with Computer Systems Validation is required for this role
- Strong knowledge of GxP Requirements, GCP regulations, 21 CFR part 11 requirements
- Must have experience with validation of IT infrastructure systems including R, SAS etc
- Experience with GxP systems validation like ELN, LIMS, QMS etc
Experience with Veeva Vault Systems