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Job Description & How to Apply Below
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 CFRPart
11 and Annexure 11 and other regulatory authorities
Well versed with Product Validation Lifecycle and Defect Management
Knowledge on Change Control Procedure
Core Competencies:
Excellent written and verbal communication skills
Strong project management skills
Should have 3 to 4 years of experience in manual testing and understanding of validation.
Analytical and critical thinking skills
Ability to influence others and move toward a common vision or goal.
Flexible and adaptable; able to work in ambiguous situations.
Resilient and tenacious with a propensity to persevere.
Forward looking with a holistic approach
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