Veeva Validation Lead Developer - Syntricate Technologies Inc
Short Hills, NJ
About the Job
Required Skills:
- Demonstratable Experience in Computer System Validation (CSV)
- Experience in software development processes (SDLC) and software testing life cycle (STLC)
- Experience in drafting, reviewing, revising, and maintaining validation documents (CSV), including Compliance Analysis, Compliance Plan, Change Control Document, User & Functional Requirement documents, Risk Assessments (Risk Register), Test (ST/UAT/Regression) Protocol, Test Defect Report, Test Summary Report, Compliance Summary Report, Traceability Matrix, Hypercare Plan, Operation Run Book and other validation & technical documentation.
- Experience in drafting Standard Operating Procedures (SOP) and Work Instructions (WI)
- Strong knowledge of JIRA, Client-ALM, qTest tools
- Knowledge of validation & testing in projects implemented using agile methodology
- Knowledge about Agile techniques like: User Stories, Continuous Testing, tasks, etc.
- Ability to take and understand the commitment to deliver the product on time.
- GxP experience is required
- Experience of validation support for 21 CFR Part 11 implementation in Pharma industries.
- Experience working within a FDA/Other regulated pharma industry.
Source : Syntricate Technologies Inc