Raimundo Ilarraza

As consultant I work in many companies such as: Amgen, J&J, Wyeth, AstraZeneca, Pfizer and Lilly del Caribe. My main functions will be resuming in: Developed Part 11 Compliance Assessment Reports, Developed Data Integrity Assessment Reports, Develop and execute computer system validation protocols, such as Validation Plan, CSV Risk Assessment, Test Plans, Test Summary Reports, Test Scripts, Traceability Matrix, Validation Summary Reports, IT project validation.

Review and approve the documentation generated as result of validation, modification, new product or technology introduction such as: Equipment Notification and Assessment form, Computer Validation Life Cycle, IQ, OQ, Experimentation Programs and Report, Process and Cleaning Validation documents, SOP and Laboratory Equipment Qualification.

Support the SAP/LIMS Interface project development. Evaluation of application options, definition of business requirements, generation of validation documents, report status to management and system owners/users.

As a chemist my primary responsibilities include: test finish product (for sales release), complaint, and stability samples.