Quality Assurance, Computer Validation and Regulatory Services: Over 25 years of progressive experience in the pharmaceutical industry. Practical, results oriented individual, able to work effectively with a wide variety of people. Ability to work on cross-departmental and cross company projects as project lead. Manage multiple tasks while maintaining established deadlines and overall project perspective. Excellent communication and interpersonal skills. Experience in Computer System Validation, Internal Quality Assurance, Data Management, Laboratory Robotics, Drug Discovery, Informatics (Bioinformatics), Project Management, Documentation, Laboratory Testing, cGLP’s, cGMP’s (Sterile Manufacturing), & cGCP’s, and 21 CFR Part 11. Specialties: Project Management, Quality Assurance, Compliance, Auditing, Validation, Computer Systems, Laboratory Systems, Clinical Systems, Computer Validation and Regulatory Services, Program & Project Management, Project Execution, Training, SOP Development. Understanding of BSL2 / BSL3 / BSL4 Containment Laboratories.Schedule a meeting with me: https://calendly.com/jfranchetti