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CSV Validation Engineer Cleanstep Pharma And Engineering Solutions

2.0 - 7.0 years

3 - 8 Lacs

Hyderabad, Pune, Mumbai (All Areas)

Work from Office

Roles and Responsibilities Conduct CSV activities such as risk assessment, gap analysis, and validation planning. Perform computer system validation (CSV) activities according to industry standards like GAMP5 and 21 CFR Part 11. Ensure compliance with EU Annexure 11 requirements for software validation. Collaborate with cross-functional teams to identify and resolve issues related to HPLC, LIMS, EMS, BMS systems. Develop test scripts and execute tests using V-model approach. Preparation, Execution, Compilation and approval of below documents (Not limited to) 1) User requirement specifications 2) Validation Plan 3) GxP Assessment 4) System Design Specification 5) Risk Assessment 6) Network (Infra) Qualification 7) Installation Qualification protocol 8) Operational Qualification 9) Performance Qualification 10) Traceability matrix 11) Validation summary report

Posted 2 weeks ago

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Qa Lead Freyr

9 - 14 years

10 - 20 Lacs

Hyderabad

Hybrid

Description 1. Understanding of various SDLC methodologies (Agile, Waterfall, V) 2. Experience in Programming or scripting languages (Java/JS etc.,). 3. Experience in designing automation frameworks (POM, Cucumber BDD, etc.,). 4. Generate Automation Test Strategy for applications deployed on Cloud. (Public and Private cloud) 5. Automate scripts using a given Selenium-based framework, Serenity based BDD framework or any open-source tools. 6. Working experience in testing Restful Webservices and APIs using frameworks or tools like POSTMAN, Rest API, etc. 7. Experience with VAPT. 8. Knowledge of Performance testing using Jmeter or any open-source tools. 9. Perform Risk Analysis of Project & automation deliverables and work towards mitigation plans. 10. Analyze requirements, perform impact analysis, and regression analysis, and communicate with stakeholders on the need for changes in requirements. 11. Mentored and managed a testing team member to meet project goals. 12. Experience with various testing types like Functional, Regression, UI/ Usability, Integration testing, etc., 13. Idea on Generative AI for testing. 14. An idea of estimation techniques for Automation testing efforts (Design and Execution). 15. Experience in testing and test planning of CI/CD-based solutions through tools like Azure DevOps. 16. Hands-on experience using ADO or any test management tools. 17. Good exposure to the AWS cloud platform. 18. Well versed with CSV and GxP process. 19. Experience preparing and reviewing various CSV documents like Test Protocol, Test Plan, Test Strategy, IQ/OQ/PQ scripts, RTM, Test Summary Report etc., 20. Experience working on CAPAS, Incident Management, FMEA Risk Assessment, Functional Risk Assessment etc., Role & responsibilities Preferred candidate profile Perks and benefits

Posted 2 months ago

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