Technical Writing

I have 6 years of hands-on computer systems validation experience including but not limited to support development, technical writing and execution of Validation Protocols, Installation Qualification, Operational Qualification, Validation Test Plans and Standard Operating Procedures in an FDA regulated environment. I have also been a Project coordinator and manager for the execution of validation protocols in a highly secure and regulated environment for quality control and documentation applications. I have extensive knowledge in Tablet, Capsule, Laser Drilling and Packaging line operations within the scope of quality control and data management.In terms of technical writing, I have excellent oral and written communication skills.Technical Skills: • Working knowledge of the FDA’s CFR 21 Part 11 compliance and regulation, cGMP, cGxP requirements for the development, validation, documentation and analysis of validation data for applications that run on SQL and Oracle databas