Diabetes & Endocrinology
Global

Diabetes & Endocrinology Experts

Lina Amornmarn

President at L. Amornmarn and Associates
Medicine
Thai Otsuka Pharmaceutical
Thailand

Biography

President Company Name L. Amornmarn and Associates (Pharmaceutical Consulting) Dates Employed Feb 2013 – Present Employment Duration 4 yrs 9 mos Location Jacksonville, Florida Area Contact Phone: (904) 302-1597 , email: [email protected] Provides consulting in area of 1. Regulatory Compliance - Maintain regulatory compliance with laws, FDA (GMP, GLP) and Global (EMEA) regulations. - Use Quality Management Tools: " Six Sigma -DMAIC (Define, Measure, Analyze, Improve, Control) & DMADV (Define, Measure, Analyze, Design, Verify), and Corrective Action and Preventive Action (CAPA) to improve quality of processes and eliminate defects (errors) in manufacturing and business process " - Computerized System Validation (IQ, OQ, PQ) Prepare Validation Plan, Test Protocols, Test Procedures, Validation Reports and SOPs. Train System Users - Wide-ranging technical writing in Regulatory Documentation these including SOPs, Investigation reports,validation documents. 2. Quality Control Raw Materials of Vitamin, Fine Chemicals and Drug products. Provided high quality, safe products and reliable services through testing and releasing. Perform Testing using Empower CDS, LIMS and HPLC, GC, NIR, UV and ICP-AES. Wet Chemistry according to cGMP and Pharmacopoeia (USP/NF, EP) Release samples via AMAPs, SAP R/3 and Atlas. ICH Harmonize testing and specifications of Compendia (USP/EP/JP/BP) 3. Research & Development (R&D) - Developed and Validated Analytical Methods for Intermediates and Raw materials that have no testing methods using State of Art Instrumentation (HPLC, GC, NIR, ICP-AES). Prepare Validation Reports for NDA Submissions 4. Business Development - Experience working with both U.S. and Global customers. (Languages: English, Thai, Chinese & Japanese). Believe in “High Quality (Right first time, Fit for intended purpose), Safe Products, Reliable Services and Customer Satisfactions” - Believe in Teamwork. “Individual Success will contribute to Team Success and lead to Company Success” - Use technology to make thing “faster and better, save time and money”

Research Interest

Pharmaceutical science

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