Software testing, Computer System Validation, Business Analyst, PV specialist
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- 570022 Mysore
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- ta | en
- 18.05.2022
Kurzvorstellung
Qualifikationen
Projekt‐ & Berufserfahrung
12/2020 – 6/2022
Tätigkeitsbeschreibung
Requirements gathering
URS preparation
Qualification and Validation activities and documentations
UAT support
Handover to Validation Owner
Prüfwerkzeuge
8/2020 – 12/2020
Tätigkeitsbeschreibung
• Expert consultancy and technical advice on the development of a tool for monitoring worldwide changes in relevant legislation in the field of safety intelligence activities
• Study of business requirements and identification of software tool for the assessment and implementation of actions within the organization due to legislation changes from time to time in the field of pharmacovigilance.
• Gathering requirements from the business users and preparation of URS and other internal documentations
• Discussions with various vendors for the required software application
• Arranging demos from suppliers and providing feedback
Requirement Analyse
4/2019 – 8/2020
Tätigkeitsbeschreibung
• Initiate Project kick-off, review of Project plan and efforts estimate.
• Review of Configuration specification (CS) document against the User requirements (URS).
• Review of Validation documents - IQ, OQ and PQ.
• Review of Software Design Specification and Upgrade Strategy document.
• Preparation of Validation Plan, Validation Summary Report, Production Summary Report.
• Drive client meetings, discussions and project progress status.
• Oversee upgrade and implementation of software on the AWS platform.
• Provide Hyper-care support after system go-live.
• On-site support during UAT phase, implementation phase.
• Provide inputs and review of CAPA document for critical issues to be presented to customer.
• Present artifacts during Internal Audit with QPPV.
• Present artifacts to auditors during external Customer Audit.
Prozessvalidierung
1/2017 – 3/2019
Tätigkeitsbeschreibung
• Software Upgrade for customers from old Pharmacovigilance Safety system to latest system.
• Prepare Upgrade strategy and Migration strategy documents.
• Participate in Workshop with the customer and gather Configuration specifications.
• Prepare Test Scripts (PQ and OQ) based on Configuration Specification.
• Deployment and Configuration of Software Application at on-site customer environment (Validation/Production Environments) for on-premise customers using IQ’s
• Deployment and Configuration of Software Application on AWS environment (Validation/Production Environments) for cloud customers using IQ’s.
• Export/ Import of customer dump and perform upgrade using IQ’s.
• Software Integration with various Product(s).
• Execute Test Scripts (PQ’s and OQ’s) on Validation Environment and gather evidences (onsite/offsite).
• Provide Hyper-Care support for 2 months duration after the application is live.
• Impact analysis of any Enhancements/Change Requirements (CRs) (after go-live) on existing configurations before implementing the same in Validation/Production environment.
Prozessvalidierung
12/2010 – 5/2017
Tätigkeitsbeschreibung
• Manual Testing of Pharmacovigilance Safety Software application.
• Perform CSV and report bugs in JIRA and track the issues to closure.
• Participate in FSD walkthrough and understand customer requirements.
• Preparation of detailed Test Case document, Test Plan, Test Environment, Work Assignment and Project documents.
• Preparation of URS, FS, CS based on the workshop with Clients.
• Review of Test Case documents, Functional Specification Documents, Release documents.
• Deployment of Software Application [using WebLogic, WebSphere, Jboss] and troubleshooting.
• Import/Export of customer dump for testing purposes.
• Configuration of Application with third party tools – Citrix, BO, Documentum, Distiller, etc.
• Integration of Application with other Product(s).
• Maintain project documents and showcase during Internal and External audits.
• Provide Application demo to the customer before the release.
• Handling Customer Call’s wherever required for understanding of Customer issues and provide solution.
• Train new joiners on Product and Testing activities.
Testing (IT)
Zertifikate
Über mich
In my previous role, worked as Business Architect for Merck KGaA as freelancer.
Weitere Kenntnisse
Master of Computer Science (2008)
Persönliche Daten
- Englisch (Fließend)
- Tamil (Muttersprache)
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