Net2Source is a Global Workforce Solutions Company headquartered at NJ, USA with its branch offices in Asia Pacific Region. We are one of the fastest growing IT Consulting company across the USA and we are hiring \"Validation Specialist\" for one of our clients. We offer a wide gamut of consulting solutions customized to our 450+ clients ranging from Fortune 500/1000 to Start-ups across various verticals like Technology, Financial Services, Healthcare, Life Sciences, Oil & Gas, Energy, Retail, Telecom, Utilities, Technology, Manufacturing, the Internet, and Engineering. Position: Validation Specialist Location: New Brunswick, NJ Duration: 6+ months on W2
Apply FDA, MHRA, and other applicable global health authority regulations to the development of computer systems supporting regulated business processes Follow SOPs and industry best practices Possess Expertise on Good Documentation and Good Testing Practices, in order to train those within the business that are less familiar. Facilitate the Computer system Validation Risk Assessment to identify governing regulations and validation deliverables during the development of the computer system Review validation deliverables for projects which are contracted to third party suppliers Maintain close communication with stakeholders and team members to keep apprised of computerized system needs, impacts on computer validation, project validation status, and other relevant issues Assist in planning, implementing, and documenting user acceptance testing Review computerized systems validation documents such as: Requirements Specification Design Specification CSV Risk Assessment Test Plans Test Summary Reports Data Migration Plan Pre/Post Executed Test Scripts Traceability Matrix Release to Production Statements
Direct and review testing Provide guidance on quality issues that affect the integrity of the data or the system Obtain and respond to QA review Participate in establishing standard quality and validation practices Independently assess compliance practices and recommend corrective actions Approve validated computer system related change requests Monitor regulatory and inspection trends and advise the business on suitable action Ability to create documents to an existing document standard. Able to develop all documentation required for a 21 CFR Part 11 validated project, including Validation Plans and Summaries.
Advanced knowledge of complete MS Office suite and Visio. Firm understanding of technology platforms as needed for project. Experience with electronic document management systems (e.g. documentum, Qumas, SharePoint etc.); application development and lifecycle management (e.g. Client ALM, JIRA, etc.); and IT service management systems (e.g. ServiceNow, SAP Solution Manager, etc) Excellent oral and written communication skills in English. Strong expertise and ability to interview and accurately interpret communication requirements of team members. Once trained, have the ability to work independently on CSV projects with minimal oversight. Ability to perform in a highly matrixed organization structure.
About Net2Source, Inc. Net2Source is an employer-of-choice for over 2200+ consultants across the globe. We recruit top-notch talent for over 40 Fortune and Government clients coast-to-coast across the U.S. We are one of the fastest-growing companies in the U.S. and this may be your opportunity to join us! Want to read more about Net2Source? Visit us at www.net2source.com Equal Employment Opportunity Commission: The United States Government does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, membership in an employee organization, retaliation, parental status, military service, or other non-merit factor. Net2Source Inc. is one of the fastest growing Global Workforce Solutions company with a growth of 100% YoY for last consecutive 3 years with over 2200+ employees globally and 30 locations in US and operations in 20 countries. With an experience of over a decade we offer unmatched workforce solutions to our clients by developing an in-depth understanding of their business needs. We specialize in Contingent hiring, Direct Hires, Statement of Work, Payroll Management, IC Compliance, VMS, RPO and Managed IT Services. Fast Facts about Net2Source: Inception in 2007, privately held, Debt free 2200+ employees globally 375+ In- house Team of Sales, Account Management and Recruitment with coast to coast COE. 30 offices in US and 50+ Offices globally Operations in 20 countries (US, Canada, Mexico, APAC, UK, UAE, Europe, , Europe, Latin America, Japan, Australia)
Awards and Accolades: 2018 Fastest Growing IT Staffing Firm in North America by Staffing Industry Analysts 2018 Fastest-Growing Private Companies in America as a 5 times consecutive honoree Inc. 5000 2018 Fastest 50 by NJBiz 2018 Techserve Excellence Award (IT and Engineering Staffing) 2018 Best of the Best Platinum Award by Agile1 2018 40 Under 40 Award Winner by Staffing Industry Analysts 2018 CEO World Gold Award by SVUS 2017 Best of the Best Gold Award by Agile1