CSV Analyst – USDM Life Sciences – Sunnyvale, CA

USDM Life Sciences is a leading global regulatory compliance and technology firm with 20 years of experience offering bold solutions that accelerate innovation, compliance, and performance in life sciences. We are currently seeking a validation analyst to support our client based in Sunnyvale, California. This resource will support our medical device customer on a variety of compliance initiatives.

Job Description:

  • 8 to 10 years of CSV experience preferably in a medical device company
  • Good Communication skills (Written, Verbal)
  • Guide IT and Business teams on Validation activities and documentation per the defined procedures.
  • Will be responsible for creating the V&V Package from a change evaluation to Validation Summary Report. [Create, review ,approve all validation documentation in accordance with DOPs]
  • Review and validate the UAT test scripts pre and post execution [ test results documentation, Objective evidence etc.]
  • Good knowledge of quality management 21CFR Part 11, GAMP, Part 820
  • Identify deviations from established process standards and provide recommendations for resolving deviations
  • Results driven with a strong customer and quality focus
  • Ability to work on multiple projects concurrently with good organization skills
  • Authoring and /or revising DOPs as and when needed
  • Ability to provide guidance on revising validation documents and protocols
  • Contribute to projects related to CSV improvements

To Apply to this Job, Please go to the website address given in the source.

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