๐๐ฒ๐ฌ๐ญ๐๐ฆ๐ฌ ๐๐ฅ๐ฅ๐ฒ is your go-to partner for top-notch global workforce solutions in the dynamic realms of medical devices ๐ฉบ, pharma ๐, biotech ๐งฌ, and IT ๐ฅ๏ธ. 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! ๐
๐ญ ๐๐๐ง๐ฎ๐๐๐๐ญ๐ฎ๐ซ๐ข๐ง๐ ๐๐ฑ๐๐๐ฅ๐ฅ๐๐ง๐๐:
- 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)
๐ ๐๐๐ ๐ฎ๐ฅ๐๐ญ๐จ๐ซ๐ฒ ๐๐ซ๐จ๐ฐ๐๐ฌ๐ฌ:
- Regulatory Affairs (Submission & Publishing: 510K, PMA, CMC, eCTD, and more)
- Supplier Quality (Non-conformances, Supplier Audit)
๐ง ๐๐ง๐ง๐จ๐ฏ๐๐ญ๐ข๐จ๐ง & ๐๐๐ฏ๐๐ฅ๐จ๐ฉ๐ฆ๐๐ง๐ญ:
- R&D Engineering
- Project Management (Agile, Scrum, PMP)
- Software Testing (QA) and Business Analysis
๐ ๐๐ข๐จ๐ญ๐๐๐ก ๐๐ซ๐ข๐ฅ๐ฅ๐ข๐๐ง๐๐:
- Bioprocessing
- Cell Culture
- Downstream Processing
- Biomanufacturing
๐ ๐๐ก๐๐ซ๐ฆ๐ ๐๐ฑ๐๐๐ฅ๐ฅ๐๐ง๐๐:
- Drug Development
- Formulation
- Drug Safety and Pharmacovigilance
- GMP Compliance
๐ฉบ ๐๐๐๐ข๐๐๐ฅ ๐๐๐ฏ๐ข๐๐ ๐๐๐ฌ๐ญ๐๐ซ๐ฒ:
- Design Control
- Risk Management
- Usability Engineering
- 510(k) Submissions
- Product Lifecycle Management
โจ 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. ๐
๐ฑ 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.
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