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Project Farma is a consulting firm that partners with cutting-edge healthcare companies across the complete supply chain (pharmaceutical, biotech, gene therapy, medical device manufacturers, distribution centers, hospitals, wholesalers). We partner with our clients to safely deliver ground-breaking treatments to patients. One of our core values is giving back. Volunteering at hospitals, supporting healthcare-related fundraisers and partnering with several nonprofit organizations is an integral part of our culture. In doing so, not only do we raise awareness of many life-threatening diseases, but also bring our team and our client's team closer to the actual patients that will be impacted by our work. CORE COMPETENCIES: Validation Farma - a Project Farma Division - Validation Program Development -- Service the Gamut of the Validation Lifecycle -- Validation Lead Planning and Strategy Development -- Computer, IT, and Equipment Validation -- Cleaning and Steaming Validation -- Process Performance Qualification Validation (24/7 PPQ support) -- Laboratory & COTS Validation Quality Audits & Assurance -- Computer and IT Audits -- CMO/TPO Auditing and Management -- Quality Assurance FTE Backfill Capital Project Organization: GMP Compliant Turnkey Solution -- Project Management, Validation Technical Lead, Engineering Technical Lead, Automation Technical Lead, Construction Management, Quality Assurance Lead -- Business Case through Implementation -- Vendor Management Engineering, Software and Automation Organization -- System Owner, Process Engineers, Automation, Software Backfill Roles -- Asset Management & Change Control Support, Policies and Procedures -- Conceptual through Detailed Design and Implementation Serialization - Track & Trace -- Global Serialization Regulations - DSCSA, ANVISA, SFDA, etc. -- Serialization and TT Audits, CMO & DC Vendor Management -- Line upgrades/controls integrated to ERP/IT Cloud HOW TO REACH US: Project Farma Corporate Office 810 W. Randolph St, 2nd Floor Chicago, IL 60607 partnerships@projectfarma.com 302.455.2488