SDET Engineer

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 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