Technical expertise to define approaches and execution of system validation activities in accordance with cGxP, CFR Parts 11, 210 & 211, Annex 11, GAMP5 and other applicable standards, regulations, procedures and industry trends such as risk-based CSA.
Coordinate and collaborate with third-parties for the creation, execution and closure of validation deliverables for various cGxP IT solutions and projects.
Develop and manage project documentation for SDLC requirements during computer system implementation projects including developing user and functional requirements, technical and functional business process flows, use case, test case and test script documents, and perform functionality, usability and testing during required project phases.
Assist in performing impact assessments and work with technical SMEs to close out IT related CAPAs
Work with project teams to select methods and techniques for obtaining desirable solutions for each project and work with QA to ensure compliance with regulations.
Participate in change control meetings and act as primary point of contact for core solution teams regarding change management, quality assurance and compliance management.