Job Title: Manager, IT QA & CSV
Introduction/Overview: N/A
Roles & Responsibilities: application validation, GxP products, drug safety, CSV practice, best practices, RxLogix, customer forums, deliverables, review, support, Requirement Specifications, Validation Plan, Test Plan, Traceability Matrix, Test Summary Report, Qualification Scripts, Validation Summary Report, SaaS Models, internal stakeholders, product owners, client users, business requirements, functional requirements, non-functional requirements, software product improvements, validation test plan, strategy, requirement traceability matrix, validation test summary report, system testing, functional testing, manual testing, automation testing, OQ, PQ, IQ, review work, feedback, quality, UAT activities, QA team, audits, Infrastructure, Operation, Performance qualification, Software Engineering Practices, requirements Analysis, Risk Assessment, Defect management, Change Control Procedure, Deviation Handling, Document Management, CAPA management, risk-based system validation approach, V-Model
Years of Experience: 14 years
Education Qualification: BE, B.Tech., MCA, B.Pharma, M.Pharma
Skills/Knowledge: GAMP 5, CFR, EU Annex 11, ICH, GDP, GTP, pharmacovigilance domain, drug safety applications, electronic QMS, DMS, Manual execution, ALM Tool based executions, training coordination, Agile/Scrum, SQL, PLSQL
Key Competencies: N/A
Domain/Industry: Pharmaceutical IT Compliance, Life Science industries
Employment Type: Full Time
Company Overview: N/A
Benefits & Opportunities: N/A
Location & Travel: Noida, India