Systems Ally

About Systems Ally

𝐒𝐲𝐬𝐭𝐞𝐦𝐬 𝐀𝐥𝐥𝐲 is your go-to partner for top-notch global workforce solutions in the dynamic realms of medical devices 🩺, pharma 💊, biotech 🧬, and IT 🖥️. We specialize in providing both contingent and permanent resources to fuel innovation and drive success in your projects. Unlock the full potential of your projects with @Systems Ally! 🚀 🏭 𝐌𝐚𝐧𝐮𝐟𝐚𝐜𝐭𝐮𝐫𝐢𝐧𝐠 𝐄𝐱𝐜𝐞𝐥𝐥𝐞𝐧𝐜𝐞: - Quality Control & Assurance (Pharma, Medical devices) - Validation (CSV, Cleaning, Equipment, Process) - Six Sigma (Lean, Kaizen, DFSS, DMAIC, Kanban, Continuous Improvement) - Statistics (SPC, CpK, Cpp, Minitab, JMP) - Mechanical (Solidworks, GD&T, Gage R&R, Electro-mechanical) - Manufacturing Compliance (CAPA, ISO 13485, 21 CFR 820, cGMP) 📑 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐏𝐫𝐨𝐰𝐞𝐬𝐬: - Regulatory Affairs (Submission & Publishing: 510K, PMA, CMC, eCTD, and more) - Supplier Quality (Non-conformances, Supplier Audit) 🔧 𝐈𝐧𝐧𝐨𝐯𝐚𝐭𝐢𝐨𝐧 & 𝐃𝐞𝐯𝐞𝐥𝐨𝐩𝐦𝐞𝐧𝐭: - R&D Engineering - Project Management (Agile, Scrum, PMP) - Software Testing (QA) and Business Analysis 🌍 𝐁𝐢𝐨𝐭𝐞𝐜𝐡 𝐁𝐫𝐢𝐥𝐥𝐢𝐚𝐧𝐜𝐞: - Bioprocessing - Cell Culture - Downstream Processing - Biomanufacturing 💊 𝐏𝐡𝐚𝐫𝐦𝐚 𝐄𝐱𝐜𝐞𝐥𝐥𝐞𝐧𝐜𝐞: - Drug Development - Formulation - Drug Safety and Pharmacovigilance - GMP Compliance 🩺 𝐌𝐞𝐝𝐢𝐜𝐚𝐥 𝐃𝐞𝐯𝐢𝐜𝐞 𝐌𝐚𝐬𝐭𝐞𝐫𝐲: - Design Control - Risk Management - Usability Engineering - 510(k) Submissions - Product Lifecycle Management ✨ Our Tailored Solutions: Through strategic consulting, cutting-edge technology, staffing support, and comprehensive training services, we ensure your projects run smoothly. Let us handle the complexities, allowing you to focus on the vital mission of developing life-saving therapies. 🌐 🌱 Innovative Work Models: We're not just about services; we specialize in innovative working models for staffing and consulting companies. From MSP (Managed Service Provider) to SOW (Statement of Work), we've got your back.