Job Summary
5 to 6 years of medical devices or diagnostic equipment manufacturing experience.
Manage the end-to-end validation documentation lifecycle including authoring, reviewing and approving protocols (URS, IQ, OQ, PQ, PV, TMV, RTM, VSR) Change Controls and Periodic Reviews, ensuring alignment with site VMP and ISO 13485.
Lead cross-functional validation initiatives for lab equipment, facilities, and non-product software supporting diagnostics platforms.
Qualify GXP equipment in compliance with FDA 21 CFR Part 11, 211. Support entire equipment lifecycle from qualification till decommissioning.
Collaborated with QA and manufacturing teams to conduct deviation management and QI/ CAPA investigations, executing root cause analysis (5 Whys Fishbone).
Applied statistical tools (ANSI/ASQ Z1.4 sampling plan) and tools such as Normality test, Distribution analysis, control charts and to support method validation, trending and ensure process robustness.
Apply GAMP5 risk-based validation framework for assessing and validating non product software systems used in quality and manufacturing environments and authoring NPSW documentations.
Driving agile change control process for release of agile production documents.
Conduct gap analyses on method validation processes, environmental monitoring, and equipment qualification, aligning them with industry and regulatory standards.
Supporting VRB meetings, documenting validation metrics, tracking goals and addressing escalation for resolution and approval.
Support external and internal audit responses by preparing validation documentation and aligning with GxP compliance and audit readiness goals.
Key Responsibilities
2. Execute Functionality Testing In Alignment With The Test Plan And Respective Test Cases, Utilizing Python For Automation Where Applicable To Enhance Efficiency.
3. Contribute To The Development Of Test Plans, Ensuring They Accurately Reflect The Requirements And Scope Of The Work Assigned To The Team.
4. Track Test Coverage, Defect Density, And Other Relevant Metrics, Compiling And Publishing Progress Reports To Inform Stakeholders Of Testing Outcomes.
5. Coordinate Discussions With The Testing Team And Interact With Clients To Provide Updates On Testing Progress And Resolve Any Issues That May Arise.
Skill Requirements
2. Proficient In Python For Test Automation And Script Development.
3. Familiarity With Testing Tools And Frameworks Relevant To Embedded Systems.
4. Solid Knowledge Of Software Testing Life Cycle (Stlc) And Quality Assurance Best Practices.
5. Excellent Communication Skills For Effective Coordination With Team Members And Clients.