Job Title: Manager – IT QA & CSV
Keywords: Manager, IT QA, CSV

Roles & Responsibilities:
Keywords: Application validation expertise, GxP products, drug safety space, SME, CSV practice, best practices, RxLogix, customer forums, deliverables, reviewing, supporting, CSV deliverables, Requirement Specifications, Validation Plan, Test Plan, Traceability Matrix, Test Summary Report, Qualification Scripts, Validation Summary Report, SaaS Models, internal stakeholders, communication, product owners, client users, business requirements, functional requirements, non-functional requirements, software product improvements, requirements review, validation test plan, strategy, requirement traceability matrix, validation test summary report, system testing, functional testing, manual testing, automation testing, OQ, PQ, IQ, work review, quality assurance, validation and documentation practices, quality testing, release, product features, product testing documents, validation and UAT activities, client product implementation projects, 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, GxP, GDP, GTP, QA best practices, regulatory guidelines, FDA, EMA, MHRA, PMDA, 21 CFR Part 11, EU Annex 11 compliance, client audits, internal audits, QMS, Continual Improvement programs, IT SOPs, training, client engagement, stakeholder management, multi-tasking, team management, performance evaluation, employee development, capacity planning, forecasting, client support, product releases, implementation, organization skills, communication skills, self-motivation, prioritization, Quality vs. Productivity.

Years of Experience: 14 Years

Education Qualification: BE/ B.Tech./ MCA/ B.Pharma/ M.Pharma

Skills/Knowledge:
Keywords: CSV, GxP, SaaS Models, requirements analysis, risk assessment, defect management, Change Control Procedure, Deviation Handling, Document Management, CAPA management, risk-based system validation approach, V-Model, GxP, GDP, GTP, QA best practices, regulatory guidelines, 21 CFR Part 11, EU Annex 11 compliance, client audits, QMS, Continual Improvement programs, IT SOPs, pharmacovigilance domain, drug safety applications, Argus, ArisG/J, electronic QMS/DMS, Manual execution, ALM Tool based executions, training coordination and management, Agile, Scrum team structure, SQL, PLSQL writing.

Domain/Industry: Pharmaceutical IT Compliance, Life Science industries

Employment Type: Full Time

Location & Travel: Noida, India