IT CSV Lead

Comtech is a woman-owned small business founded in 1998 and headquartered in Reston, VA. We offer IT solutions across the disciplines of program/project management, applications development, infrastructure, Cyber security, and enterprise content/data management services. We have developed our methodologies and processes based on the IT Infrastructure Library (ITIL) v.3 Framework across enterprise infrastructure operations. These methodologies and processes are reinforced through our organization’s externally accredited certifications, which include ISO 9001:2008 Quality Management System (QMS), ISO/IEC 20000-1:2011 IT Service Management Systems (SMS, corporate ITIL certification), ISO 27001:2005 Information Security Management System (ISMS), and CMMI-DEV Level 3.Job Description

Job title: IT CSV Lead.Location: Raritan, NJDuration: 3 months + to start and positively will get extended.Skills Required:Total experience – 7+ yrs.Good Knowledge in Validation Testing, Agile and SDLC process.Thorough knowledge in remediation process, decommission plans, preparing compliance plan, perform compliance analysis, gap analysis, risk assessment.Responsible for system release to production following change controls, CAPA.Good knowledge in performing validation for cloud-based/COTS applications.Provide trainings on CSV and GxP procedures and policies to offshore team.GxP knowledge - worked in pharma and have knowledge in testing phases and deliverables.Good knowledge of HPQC, ALM would be an added advantage.Able to work independently.He/she has to do the complete documentation in writing test protocols, preparing summary report and coordinate with business in authoring test scripts.Author UAT scripts, execute, work closely with business in understanding the requirements.Good communication skill is mandatory.Dry Run all scripts in the Dev environment.Qualifications

Qualifications:Bachelor's degree in a relevant field.

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