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·         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.