· Assist in updating the implementation lifecycle documents (i.e., Business Process Documents, Configuration Design Specification, Technical and Functional Design Specification).
· Create /Review software validation plans, Qualifications test protocols, traceability matrices, reports and all software deliverables within the scope of validation.
· Assisting with the verification, validation and debugging of software applications.
· Participates in root cause analysis for problem solving.
· Support release management activities by reviewing and ensuring the pre-requisites are release prior to the release.
· Develop and maintain test plans, test scripts and user acceptance tests and manage the execution of test plans.
· Perform risk assessment document using risk assessment and identify the gaps and risk factors and risk mitigation plans of the system preparing of function and configuration.
· Coordinate with cross-functional team for post approval of qualification protocols and validation summary report.
· Assist in documenting the Quality System support documentation including Standard Operating Procedures (SOP), Work Instructions (WI) and training materials.
This position requires a minimum of a bachelor’s degree in Computer Science, Computer Information Systems, Information Technology or a combination of education and experience equating to the U.S. equivalent of a Bachelor’s degree in one of the aforementioned courses