· Trackwise configuration, implementation, URS/FRS writing
· Experience in Software Development Lifecycle (SDLC).
· Experience in QA Methodologies, designing, reviewing and approving Test Plans, systems and UAT test scripts and Test procedures.
· Experience on various FDA standards (21 CFR Part 11, 210, 211, 820)
· Experience is creation of SOPs.
· Knowledge of FDA guidance’s and industry standards (i.e., GAMP)
· Strong verbal and written communication skills.
· Able to work as a team player, lead a team or accomplish tasks without supervision.
· Ability to work with remote teams and support several changes/projects simultaneously.
· Flexibility to work with an onshore/offshore model.
· Participate in the development of strategic compliance deliverables to support applicable regulations and internal policies
· and to ensure systems to be developed adhere to corporate SDLC methodology.
· Drive understanding and adoption of Quality and Compliance standards.
· Ensure Quality & Compliance requirements are considered in any initiative or major change request.
· Ensure the compliance deliverables are updated and kept current with all applicable changes.