About TSR :
TSR is a relationship-based, customer-focused IT and technical services staffing company.
For over 40 years TSR, Inc. and its wholly owned subsidiary, TSR Consulting Services, have prospered in the Information Technology staffing business, earning the respect of companies both large and small with well refined candidate screening, timely placement, and a real understanding of the right skill sets required by our clients.
Mission & Vision
- We do not believe in building a vision around the company but building a company around our vision, which is simply;
Every employee's voice matters, their effort is appreciated, and their talent is rewarded.
We challenge each employee daily, to raise the bar on how we treat our consultants and candidates. For far too long in this industry, candidates have been ghosted, lied to, or placed at a client and then forgotten about. Each day our staff works tirelessly at qualifying and placing, top talent with our clients, in a compassionate and caring manner.
Not every candidate is a match for the job, but every candidate and consultant will be treated with respect and professionalism.
Validation Specialist
Job Description
Location : New Brunswick, New JerseyType : ContractJob #81676Our client, a leading pharmaceutical company, is hiring a Validation Specialist, on a contract basis.
Job ID # : 81676
Work Location :
New Brunswick or Lawrenceville, NJ - 50% on site
Education / Experience :
6 years' experienceExperience with electronic document management systems (e.g. documentum, Qumas, SharePoint etc.); application development and lifecycle management (e.g. HP ALM, JIRA, etc.); and IT service management systems (e.g. ServiceNow, SAP Solution Manager, etc)Knowledge / Skills :
Advanced knowledge of complete MS Office suite and Visio. Firm understanding of technology platforms as needed for project.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 structureResponsibilities :
Apply FDA, MHRA, and other applicable global health authority regulations to the development of computer systems supporting regulated business processesFollow SOPs and industry best practicesPossess 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 systemReview validation deliverables for projects which are contracted to third party suppliersMaintain close communication with stakeholders and team members to keep apprised of computerized system needs, impacts on computer validation, project validation status, and other relevant issuesAssist in planning, implementing, and documenting user acceptance testingReview computerized systems validation documents such as :Requirements SpecificationDesign SpecificationCSV Risk AssessmentTest PlansTest Summary ReportsData Migration PlanPre / Post Executed Test ScriptsTraceability MatrixRelease to Production StatementsDirect and review testingProvide guidance on quality issues that affect the integrity of the data or the systemObtain and respond to QA reviewParticipate in establishing standard quality and validation practicesIndependently assess compliance practices and recommend corrective actionsApprove validated computer system related change requestsMonitor regulatory and inspection trends and advise the business on suitable actionAbility 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.Pay Range : $77-$79 / hr
Salary : $77 - $79
