Careers

·       Develop, review, and approve validation policies, procedures, plans and protocols for the implementation of GxP procedures for the infrastructure and computer systems

·       Analyze and test the 21 CFR Part 11 compliance tracking applications that are designed to track down the applications currently being used to comply with FDA regulations and GAMP

·       Establishment of key deliverables of computer and automated validation; User Requirement Specifications (URS), Functional Requirement Specifications (FRS), GxP Risk Assessment (RA), IQ/OQ/PQ Test Scripts, Requirement Traceability Matrix (RTM), Validation Summary Report (VSR)

·       Develop Validation and Test Plans, specifications, supplier assessment and compilation of the data and results into final reports

·       Implement formal testing of GxP computerized systems including identifying and implementing tools, setup of testing, documentation, approval, and delivery

·       Focus on problem identification and involved in processing of CAPA (Corrective Action and Preventive Action) reports to ensure compliance with established procedure

·       Review and approval of the change request documentation which will be created as part of the regular Operational and Support of the systems

·       Making sure that all the project teams follow SDLC SOP and create appropriate SDLC deliverables that will be approved and stored in LEADs (document management system)

Qualification:

A bachelor’s degree in Pharmaceutical Science or a closely related field or a combination of education and experience equating to the U.S. equivalent of a Bachelor’s degree in one of the aforementioned subjects.