| Validation Lead with Lab Vantage at Remote, Remote, USA |
| Email: [email protected] |
| From: Ryan, nitya software [email protected] Reply to: [email protected] Role: Validation Lead with Lab Vantage Job Location : NJ Responsibilities: Validation Lead with 10+ years of experience to with Lab Vantage LIMS implementation team who would be responsible for : Planning and implementation of validation projects for Compliant GxP Computerized Systems, particularly for Lab Vantage LIMS system Creation, Review and in-time delivery of the Validation documentation but not limited to the following: o Computer Systems Validation Plan and Report o Data Migration Plan and Report o URS/FS/CS, Risk assessment o Test plan and Report o Test cases creation and execution Manage all facets of assigned validation projects while maintaining strong communication on project status and assistance needed Build/Set-up Validation and qualification practices grounds up in line with GxP for both GMP and GLP Coordinate with the application vendor for clarification on the open defects and on the validation deliverables at vendor side Qualifications * Experience in Validation (entire duration) in the Life Sciences and Clinical trial related * Experience managing projects (Lead Exp duration) * Experience in a regulated manufacturing environment * Experience with process and equipment validations * Experience with LIMS and Lab Vantage would be a plus * Deep understanding of GxP (clinical, pharmacovigilance, laboratory etc.) regulations, 21 CFR Part 11 & other regulations Keywords: New Jersey |
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| Fri Jan 12 19:32:00 UTC 2024 |