Highlights:-> Well acquainted with the Software Development Life Cycle (SDLC) and Software Test Life Cycle (STLC).> Working knowledge on different SDLS's viz Waterfall, V-model and Agile Methodologies.> Proficient with Bug tracking tool JIRA, JIRA workflow.> Good knowledge on PMP, ISO 13485 standard, GLP and 21 CFR Part 11. > Understanding of Healthcare regulations and applying validation knowledge to test the devices within their frameworks> Strong communication skills along with a remarkable ability to gather requirement to bring out quality product.> Owning the verification activities from program initiation till post market support.> Responsible for various types of testing, including regression, performance, stress, unit, integration, and security testing. > Project management and project deliverables wrt Software Verification activity.> Managing VE team wrt resource allocation, task assignments, accessing task... > Extensive knowledge on use and maintenance of different flavors of Class II medical devices- Tof-MS, Q Trap MS, QQQ-MS,HPLC, GC and Capillary Electrophoresis. > Maintenance of Bioanalytical lab, LCMS instruments, procurement of lab items, reagents, standards. > Working experience on different CDS-AB-Sciex: Analyst, DiscoveryQuant, SciexOS, LibrarayView. Waters: MassLynx, UNIFI, Empower3 (Workstation and Enterprise), Agilent: Chemstation, Shimadzu: LC solution & ClassVP, ProteinSimple: Compass-iCE .> Business Travel: California (US) and Concord (Canada) for Requirements gathering, discussion on new Features, implementation and timelines. > EHS process, documentation and maintenance for Mass spec's/Analytical lab.
Listed skills include Sdlc, Requirements Analysis, Service Delivery, Manual Test Execution, and 21 others.