CSV/CSA consultants - Katalyst Healthcares & Life Sciences
South Plainfield, NJ 07080
About the Job
Resource should be an expert in validation and compliance of Pharma processes, active involvement in qualification and documentation of applications and tools.
Skills Required: Quality Assurance, Compliance Analyst, Experience in CSV Practices, Experience in GAMP5 CFR Part 11.
Main activities to be performed in GxP testing are as below.
Validation Planning: Based on System Risk assessment and Data Classification assessment create the validation plan.
Design Build and Test: Perform IQ, OQ and PQ Based on the validation plan.
Validation Reporting: Create the Test Summary Reports and Release Notes documenting details of the testing performed including open defects if any.