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.
- 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
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