Job Responsibilities:
- Test Management in Pharma domain
- GxP Systems Testing and Validation
- Test Design/Execution/RTM in ALM
- Good Communication skills for Customer Interactions
Qualifications:
- 12 years' experience in validating systems and experience in GxP related applications.
- Perform review for GxP systems to ensure compliance with regulatory requirements as per the customer SOPs.
- Expertise on end-to-end validation of GxP applications and able to perform document/process compliance analysis.
- Adept with Agile and Waterfall methodology.
- Requirement specifications, functional specifications/user stories/acceptance criteria and ensures completeness of test script with traceability.
- Ensures risk assessment is completed for all the requirements and test cases are designed in reference to the risk levels identified for the requirements.
- As an onsite Test Lead managing testing teams on the entire validation testing life cycle including test planning, test case design, test execution, and defect management activities.
- Able to author Validation Plan and compile Validation Summary Report, generating RTM reviews, and ensuring that the operational procedure for the application is ready.
- Able to handle change requirement related implementation for small changes.