Job Description :

Hi All,

PFB urgent Contract requirement with our direct client . Complete JD is below. If you are interested pls share your resume ASAP. 

Role : Validation Lead

Exp : 10+yrs

Location : Raritan, NJ

Duration : Long term 

Job Description: 

·  Apply FDA, 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

·  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:

·       Compliance Analysis

·       Compliance plan/report

·       Requirements Specification

·       Design Specification

·       CSV Risk Assessment

·       Test Plans

·       Test Summary Reports

·       Data Migration Plan/report

·       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.

·       Experience 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)

·       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



Client : Direct Client


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