Website Syntricate Technologies Inc
Syntricate Technologies Inc
Company : Syntricate Technologies Inc
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.