Validation Specialist

08543, Princeton
Dec 01, 2020
Required Education
Bachelors Degree
Position Type

TSR is a premier National U.S. Staffing company with over 50 years of staffing excellence. Our client is hiring a Computer Validation Specialist on a Contract basis in Princeton, NJ. 

Manager would like a candidate who can author Validation Summary Reports and Validation Plans. Someone who can work independently.

Manager would like to see the following on all resumes:

• 5+ years of CSV
• 5+ years of GXP
• 3+ years of ALM
• 2+ years of Data Integrity

Job Description:
5+ years experience
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

Sincerely yours,

Nitin Patel Senior Technical Recruiter

TSR Consulting Services, Inc.

379 Thornall Street, 6th Floor, Edison, NJ  08837

Phone: 646-668-4354