Senior level technical writer authoring validation documentation for lab automation systems; continuous service in Pharmaceutical Quality Control and Quality Assurance for over 40 years; supported both Pharmaceutical Manufacturing and Medical Device operations; specializing in 21 CFR Part 11 since 1997; have done project management and validation documentation for LIMS and Data Acquisition systems; have done some development for LIMS systemsSpecialties: Senior level experience working with LabWare LIMS (LabWare Certified Consultant)CSV experience with StarLIMS
Listed skills include Computer System Validation, 21 Cfr Part 11, Lims, Validation, and 17 others.