CSV Lead

job
  • Katalyst Healthcares and Life Sciences
Job Summary
Location
South Plainfield ,NJ 07080
Job Type
Contract
Visa
Any Valid Visa
Salary
PayRate
Qualification
BCA
Experience
2Years - 10Years
Posted
01 Feb 2025
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Job Description
Responsibilities
  • Ensure the lab instruments are calibrated prior to performing IQ/OQ and certify.
  • Produce GxP documentations for the instrument software validation.
  • Own change controls and deviation management
  • Prepare and execute IQ/OQ protocols for lab instruments.
  • Prepare validation plan and summary reports.
  • Collaborate with business team for completion of GxP activities as per project plan
What are the top skills required for this role?
  • Life Sciences Domain knowledge
  • Computer System Validation
  • Clinical Research lab instrument validation
  • 21 CFR part 11
  • Client ALM
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