Veeva Validation Lead Developer

Job Title

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.