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 C...
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