Ephrem Hunde
Senior Consumer Safety Officer at Fda
Based in Orangeburg, United States
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Seniority
Manager
Department
Other
Location
Orangeburg
Industry
Architecture and Planning
Company size
18
Contact information
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e•••••••@fd-a.co.za
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Background
About Ephrem Hunde
PhD chemical engineer with diverse and dynamic professional career in government regulatory agency (FDA), medical device, and specialty materials industries. Experience in Facilities and Manufacturing Process review for drug applications (ANDA, NDA, BLA), facilities compliance review, and DS/DP manufacturing facilities inspection. Validation and verification of cGMP manufacturing processes and equipment installations (IQ/OQ/PQ) in in-vitro diagnostics medical device industry. Expertise in product formulation, process & product development, new product introduction, and scale-up in polymer based specialty materials industry. Strong problem solving, experimentation, and statistical data analysis skills. Interfaced with cross-functional teams in R&D & manufacturing to optimize processes & commercialize new products. Six-sigma green belt certified.
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