Dear Vendors,
I hope this email finds you well.
I hope this email finds you well.
Role: CSV Engineer
Location: Raritan, NJ (Hybrid 3 days onsite)
Client:-HCL
Location: Raritan, NJ (Hybrid 3 days onsite)
Client:-HCL
Job description:
Must Have: The resource must have experience in Tool validation – ServiceNOW, JIRA, Automation tools
Job Details:
•3-7 years’ experience in Computer System Validation or Quality management or Business Analysis in GxP application area.
•Has working experience in any one or two of the following domains Tool validation like ServiceNOW, Automation tools, JIRA
•Guide the project team with the right set of applicable project deliverables based on project type and category while catering to the SDLC
•Application of FDA guidance’s and industry standards (i.e., GAMP). Strong understanding on 21 CFR Part 11 and Risk Based Approach with the ability to guide the project teams
•Expertise in documenting / guiding various SDLC Deliverables including Requirements Specification/ User Stories, Criticality Assessment, Test Plan, Design Documentation, Validation Plan, Risk Assessment, Validation Strategy / Test Planning, Validation / Test Summary, Requirement Trace Matrix.
•Possesses strong communication skills to interact with business stake holders (Technology Leader, Project Manager, Business Owner
•Ability to work with project team to facilitate interaction between Project team and Business Stake holders
•Ability to manage and provide guidance / train the team on Policies, end to end SDLC Process, Procedure and Tools
•Trains the project team on the relevant procedures associated with different SDLC processes and Tools
•Strong in Project Management tools like JIRA
•Manage Project priorities based upon identified risks.
•3-7 years’ experience in Computer System Validation or Quality management or Business Analysis in GxP application area.
•Has working experience in any one or two of the following domains Tool validation like ServiceNOW, Automation tools, JIRA
•Guide the project team with the right set of applicable project deliverables based on project type and category while catering to the SDLC
•Application of FDA guidance’s and industry standards (i.e., GAMP). Strong understanding on 21 CFR Part 11 and Risk Based Approach with the ability to guide the project teams
•Expertise in documenting / guiding various SDLC Deliverables including Requirements Specification/ User Stories, Criticality Assessment, Test Plan, Design Documentation, Validation Plan, Risk Assessment, Validation Strategy / Test Planning, Validation / Test Summary, Requirement Trace Matrix.
•Possesses strong communication skills to interact with business stake holders (Technology Leader, Project Manager, Business Owner
•Ability to work with project team to facilitate interaction between Project team and Business Stake holders
•Ability to manage and provide guidance / train the team on Policies, end to end SDLC Process, Procedure and Tools
•Trains the project team on the relevant procedures associated with different SDLC processes and Tools
•Strong in Project Management tools like JIRA
•Manage Project priorities based upon identified risks.
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