Hi,
Hope you are doing well!
Please find the Job description and let me know if you are interested.
Job Title : CSV Engineer
Location- Raritan, NJ(Hybrid 3 days a week)
Duration: Long Term
Position type : Immediate
Job Summary:
Skills- Computer System Validation, GxP Regulations
SS- Validating Lab Information Management System – LIMS, LIMS Rollover
JD-7-10years’ experience in Computer System Validation of Lab Information Management System – LIMS
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 documentingguiding various SDLC Deliverables including Requirements Specification User Stories, Criticality Assessment, Test Plan, Design Documentation, Validation Plan, Risk Assessment, Validation StrategyTest Planning, ValidationTest 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.
Abhishek kishore
SunRay Enterprise Inc
Email: AKishore@sunraycorp.com
www.linkedin.com/in/abhishek-kishore-3aa531113/
Web : www.sunraycorp.com
From:
Abhishek Kishore,
Sunray Enterprise Inc
akishore@sunraycorp.com
Reply to: akishore@sunraycorp.com