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
Apply on company website Raritan, NJ On-site Contract
Comtech LLC is hiring an IT CSV Lead
About company
If you are a federal, state, local, or commercial organization, you can achieve great success with the right technology. We provide our clients with the information they need to implement innovative technologies and tools that streamline decision-making, reduce costs, and improve operational efficiency.
Comtech specializes in cybersecurity, infrastructure management, IT modernization, and smart talent management. The company holds prime contracts including GSA Schedules, ID/IQ task order contracts, and Government-Wide Acquisition Contracts (GWAC), serving government and commercial clients.
Comtech is CMMI Level 3 certified in Development and Services and maintains ISO 9001 certification, with ongoing renewals for ISO 20000 and ISO 27001. The company is committed to quality and leverages ITIL v.3 Framework methodologies across enterprise operations.