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
Core Competencies:
Excellent written and verbal communication skills
Strong project management skills
Should have 3 to 4 years of exper...
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
Core Competencies:
Excellent written and verbal communication skills
Strong project management skills
Should have 3 to 4 years of exper...
Apply for this Position
Ready to join Qinecsa Solutions? Click the button below to submit your application.
Submit Application