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
Rashmi