Job Description

Job Responsibilities:

  • Validation expertise on PV applications
  • Validation and Testing (Validating the product to meet the requirements)
  • Define the Test Scenarios based on the requirements
  • Authoring and Reviewing OQ/UAT Test Cases
  • Executing the Test Cases
  • Requirements Analysis, Risk Assessment, Profiling and Mitigation
  • Managing complete life cycle of qualification documents like IQ, OQ and UAT


Technical Competencies:

  • SQL Knowledge
  • Argus validation in both English and Japan screen
  • Knowledge of Pharmaceutical/ Life Sciences/ Drug Safety domain and products
  • Knowledge of test automation
  • Knowledge of regulatory guidelines like GAMP 5 RBA, 21 CFRPart11 and Annexure 11 and other regulatory authorities
  • Well versed with Product Validation Lifecycle and Defect Management
  • Knowledge on Change Control Procedure
...

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