· Participate on computerized system validation and implementation project teams.
· Author computer system validation documentation ensuring compliance with applicable FDA Regulations that is 21CFRPart11 and 21CFRPart820.
· Follow GAMP5 practices for authoring and reviewing Validation Documentation.
· 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.
· Establishment of key deliverables of computer and automated validation; User Requirement Specifications (URS), Functional Requirement Specifications (FRS), GxP Risk Assessment (RA) and IQ/OQ/PQ Test Scripts, Requirement Traceability Matrix (RTM), Validation Summary Report (VSR).
· Develop Validation and Test plans, specifications (e.g. URS, FRS, IQ, OQ, PQ, UAT, RTM, RRA etc.) supplier assessment and compilation of the data and results into final reports.
· Review requirements and protocols for covering the quality, compliance, security and data processing elements of the systems.
· Create Design Documents, Test Plans and Deployment plans for the Applications throughout the Integration Cycle
· Testing during various phases of test lifecycle throughout the Defect Tracking and Resolution cycles.
· To play a crucial role in ensuring that product development teams deliver functionally correct and complete software in a regulated environment.
· Support product innovation by developing novel and creative software validation processes and encourage automation early and often.
Bachelor’s Degree or its equivalent in Pharmaceutical Science.