Test Lead

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.