Companies invest significant capital in designing and developing innovative products, following the correct process for regulatory approval and investing in the manufacturing personnel and equipment to bring their products to the world. Design control oversight, setting up risk management files, V&V, QMS oversight and quality strategy leadership are imperative to mitigate risk, protect your investment, ensure product integrity and patient safety.
Our business is people and helping you identify, attract and retain the top Quality talent to support your US and international strategies for your organization. SSI helps client companies identify, attract and retain the right Quality talent to support their innovative thinkers, support NPD, set up and oversee supplies/vendors, support validation and support manufacturing to ensure the safety and quality of their products in the marketplace.
We have the experience, skill and resources in our Pharma/Biotech Quality practice to meet your needs in a variety of functional areas at the VP, Director, Manager and Mid-Level:
- Design Quality & Design Controls
- Aseptic Practices and Clean Room Operations
- Media Fill & Sterile Injectables
- V&V, Validation: IQ/OQ/PQ
- QMS Auditing, Gap Analysis, Remediation & Implementation
- Review Batch Records & Certificates of Analysis
- cGMP, ISO 15378, 14971,
- Supplier Quality, API Suppliers & CMO oversight
- Statistical & Auditing techniques
Our clients range from start-ups, private small businesses, mid cap companies to publicly traded and top 30 global medical device and biotech companies in the world.