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Computer Validation Lead for Sterile Mfg Facility |
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A parenteral compounding, filling, lyophilization and finishing GMP compliant facility capable of producing injectables for the United States, European Union, Japanese Markets and the world market. This facility utilizes state-of-the-art isolation technology for the manufacture of sterile pharmaceutical products (therapeutic protein products). The facility size is approximately 250,000 sq. ft. |
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Multiple Projects for a Large Pharma Mfg Facility |
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A large scale pharmaceutical manufacturing facility supporting the production of several liquid, semi-solids and solid oral dose products. We have been involved in several new facility projects at this location. |
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Corporate Wide Part 11 Strategy Services |
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Worked with several pharmaceutical and biotech companies in developing corporate and facility wide 21 CFR Part 11 strategies.
Projects span from preclinical/clinical departments to manufacturing and QA/QC labs. |
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