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CSV Lead

Katalyst HealthCares & Life Sciences
San Francisco, CA
Full-time

Responsibilities and Requirements :

  • Good verbal and written communication skills.
  • Ability to work on multiple projects concurrently with good organization skills.
  • to years of experience in computer system Validation preferably in a medical device / Pharmaceutical company.
  • Will be responsible for creating and maintaining the V&V Package.
  • Good knowledge of IQ / OQ / PQ.
  • Provide recommendations for resolving deviations from established processes.
  • Review and approve the UAT test scripts pre and post execution.
  • Results driven with a strong customer and quality focus.
  • Hands on experience using Agile and Client ALM applications.
  • Ability to provide guidance on revising validation documents and protocols.
  • Guide Project teams on Validation activities and documentation per the defined procedures.
  • 30+ days ago
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