1. Job Title: Manager – IT QA & CSV
2. Introduction/Overview: NO DETAILS FOUND
3. Roles & Responsibilities: Provide application validation expertise on GxP products for drug safety space, be an SME in CSV practice and ensure best practices are followed consistently within RxLogix, represent RxLogix to customer forums and ensure confidence in our deliverables, be accountable for reviewing and supporting key CSV deliverables – Requirement Specifications, Validation Plan, Test Plan, Traceability Matrix, Test Summary Report, Qualification Scripts and Validation Summary Report, understanding of implementing projects on SaaS Models, coordinate with internal stakeholders and communicate effectively, interact with internal product owners and client users to understand business, functional & non-functional requirements, or improvements for software product, review, understand and ensure that the requirements are detailed, un-ambiguous, complete, and testable, author and/or review validation test plan, strategy, requirement traceability matrix, validation test summary report for product releases based on project / product requirements, lead, mentor & guide the testing team members for all type of testing activities and artefacts including (but not limited to) system testing, functional testing, manual testing, automation testing, OQ, PQ, IQ, etc., review the work performed by the team members, provide feedback to ensure adherence to the validation and documentation practices and be accountable for the quality of work products created by the team, accountable for quality testing and release of all product features and product testing documents/artefacts with high quality, lead validation and UAT activities and artefacts for client product implementation projects, support and liaise with internal QA team for internal and external audits for product/project documents and artefacts, understanding needs of Infrastructure, Operation and Performance qualification in alignment with Software Engineering Practices, requirements Analysis and Risk Assessment, Profiling and Mitigation in collaboration with the SME, sound Defect management skills, provide adequate understanding and expertise on Change Control Procedure, Deviation Handling, Document Management and CAPA management, understanding of risk-based system validation approach and V-Model.
4. Years of Experience: Minimum 14 years of experience
5. Education Qualification: BE/ B.Tech./ MCA/ B.Pharma/ M.Pharma from recognized institute with good academic scores
6. Skills/Knowledge: GAMP 5, CFR, EU Annex 11, ICH, GDP, GTP, pharmacovigilance domain, drug safety applications (Argus or ArisG/J), electronic QMS/DMS, Manual execution and ALM Tool based executions, training coordination and management, Agile/Scrum team structure, SQL and PLSQL writing
7. Key Competencies: NO DETAILS FOUND
8. Domain/Industry: Pharmaceutical IT Compliance areas and CSV, Life Science industries
9. Employment Type: Full Time
10. Company Overview: NO DETAILS FOUND
11. Benefits & Opportunities: NO DETAILS FOUND
12. Location & Travel: Location: Noida, India. NO DETAILS FOUND