• Application Testing-L3 (Mandatory)
• Pharma Domain-L3
• HP Application Life Cycle Management - HP Quality Center-L3
• Clinical Trials Management System (Impact)
• Electronic Data Capture and Management Solution (Rave EDC)
• Enterprise Content Management (ECM)
• Regulatory Information Management Systems
• Any Enterprise Integration Platform Dell Boomi, Informatica, API gateway, SFTP Go anywhere.
• Overall 12+ years of experience in IT with good program management and leadership skills
• 2+ years of experience in Pharma GxP regulated
• Managing and leading teams in end-to-end testing process. Activities include Test Team management, Test Plan preparations, Test Metrics formulation, Generation of Reports, Regression Test Effort Estimations and assignment of work-items, Client interactions, and coordination between the various stakeholders at Client location
• Good understanding & implementation knowledge of FDA 21 CFR Part 11, ICH, GAMP 5 guidelines and other GxP regulations
• Quality Assurance & Validation testing experience in COTS applications, Web Testing, API Testing, Integration testing, Functional & Regression Testing
• Strong knowledge on SDLC, Agile, V- Model validation methodologies
• Experience in reviewing Validation Plan, User Requirements Specification (URS), Functional Specifications (FS), Configuration / Design Specification (CS/DS), Traceability Requirements Matrix (TRM) Functional Risk Assessment (FRA), Standard Operating Procedure (SOP) and related Work Instructions (WI), Test Plan, Deviation Reports.
• Understanding of complex Enterprise architectures and laying down Test Strategies.
• Do the detailed planning, work with architecture & operations, Identify the scope of end to end testing, look at deployments for next 12 months
• Must have good understanding of STRIDE domain
• Experienced in HP ALM & JIRA (Issue tracking)
• Pharma integration experience in one or more in the following systems:
* Impact from Parexel / any other enterprise CTMS
* Rave from Medidata / any other enterprise CDMS
* SubWay from Open Text / any other enterprise GxP document management systems
* Horizon from PlanView / any other enterprise Project planning tool.
* Statistical Analysis and Reporting in Clinical Trials
* Aris Global RIM / any other Regulatory Information Management Systems
* Any Enterprise Integration Platform Dell Boomi, Informatica, API gateway, SFTP Go anywhere.
* Data migration from legacy systems and associated CSV testing.
Application Testing
Pharma Domain, HP Application Life Cycle Management - HP Quality Center
Experience : 5-8 years
Job Code : 606681
Location : Hyderabad
Industry Type : Pharma
Functional Area : Test Deployment
End Date : 10th July, 2018
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