What are the responsibilities and job description for the GXP Validation Engineer position at Katalyst CRO?
Responsibilities
- 12 years' Experience in Validating systems and Experienced 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 is 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 a onsite Test Lead managing of testing teams on entire validation testing life cycle on test planning, Test cases design, test execution and defect management activities.
- Able to author Validation Plan and compile Validation Summary Report and generates RTM Reviews and ensures that the Operational Procedure for the application is ready.
- Is able to handle Change Requirement related implementation for small changes.
- Test Management in Pharma domain.
- GxP Systems Testing and Validation.
- Test Design/Execution/RTM in ALM.
- Good Communication skills for Customer Interactions.
