IT CSV Lead

Reposted 13 Days Ago
Be an Early Applicant
Raritan, NJ, USA
In-Office
Senior level
Other
The Role
The IT CSV Lead will manage validation projects, perform compliance analysis, and provide training. Requires knowledge in validation for cloud-based applications and GxP.
Summary Generated by Built In
Company Description

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, NJ

Duration: 3 months + to start and positively will get extended

Skills Required:

  • Total experience – 7+ yrs.
  • Good Knowledge in Validation Testing, Agile and SDLC process
  • Responsible for managing validation projects.
  • 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 mandate.
  • Dry Run all scripts in the Dev environment

Qualifications

Qualifications:

  • Bachelors degree in relevant field. 

Additional Information

**Please share me your updated word copy of Resume.

**I Appreciate, if you can  refer  someone who is looking for this position.

Contact:

Nayan Hazare

IT Recruiter at Comtech LLC

Call- 703-962-6656

nhazare@ comtechllc.com

Skills Required

  • Total experience - 7+ yrs
  • Good Knowledge in Validation Testing, Agile and SDLC process
  • Thorough knowledge in remediation process, decommission plans, compliance and risk assessments
  • Good Knowledge of HPQC, ALM would be an added advantage
  • Bachelors degree in relevant field
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The Company
Reston, VA
64 Employees
Year Founded: 1998

What We Do

Comtech is an award winning, customer-oriented, full-service IT solutions provider serving the Civilian Federal Government, the Department of Defense and other Agencies. In the finance and medical sector, Comtech offers IT solutions to help financial and healthcare organizations comply with regulatory requirements and helps them reduce cost while increasing strategic agility.

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