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Hi ::
We do have immediate opening for SQA – CSV Validation Engineer Please share me your updated resume along with rate, visa status and availability.
This is onsite position and client is looking only locals or who are available immediately to relocate to Princeton, NJ to work at onsite
Requirement details:
Job Title: SQA – CSV Validation Engineer
Location: Hamilton, OH 45011 (Day1 onsite)
Duration : 12+ Months
Job Description:
8-10+ Years of Overall IT Experience
Responsible for preparing and executing test documentation for GMP computerized systems as well as providing support in the troubleshooting of issues during test execution.
You should have excellent understanding of 21 CFR Part 11, ICH standards, EMA and FDA (GxP) regulations, and GAMP methodologies.
Coordinate with multi-disciplinary validation team and be responsible for the validation of automated equipment and control systems
Create and modify validation documentation including but not limited to: User Requirements Specifications (URS) Design Reviews (DR) Criticality assessments CSV protocols (SAT, IQ, OQ, PQ) which verify if the system is compliant to regulatory and client requirements Reports which summarize the results of the protocol executions Exception reports which identify defects or issues during test execution Review vendor documentation
Requirement Specification document review and approvals
System Implementation Plan Review
System Implementation Summary Report Review
Review and Pre-Approve ST/UAT Test Scripts in ALM
Create, Update RRA (Regulatory Risk Assessment) and obtain approvals
Post Execution Review and Post Approvals in ALM
gR Implementation Approvals
Retirement Plan Revew
Retirement Summary review Deliverables:
Requirement document
Validation/Test Plan
Requirement Traceability Matrix
Change Requests
Impact assessment document
Test/Validation Summary Report
“In case I missed your call, Email is the best way to reach me ”
Thanks & Regards
Shawn Marsh
Star Technology Solutions Inc
Email : [email protected]
Website: http://startechsinc.us
Note : If you have received this mail in error or prefer not to receive such emails in the future, please reply with “REMOVE” in the subject line and the email id(s) to be removed. All removal requests will be honored ASAP. We sincerely apologize for any inconvenience caused