A dynamic, logical thinking, performance driven IT professional, with 15 years of experience out of which fourteen years of Lotus Notes Development including 5 years of Business Analysis experience and one year of Lotus Notes Administration experience using Notes version 7.01 & Notes version 8.4. Possess full knowledge of Software Development process including requirements definition, prototyping, Proof of concept, design,...
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SDLC, Agile, Scrum, Java, Project Management, Oracle, 21 CFR Part11, GCP, HIPAA, HL7, Software Architect , CTO, Healthcare, Clinical Research , Offshore Development, Open source technology, EDC, RDC
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GCP, ICH, 21 CFR 50, 21 CFR 56, 21 CFR 312, 21 CFR 812, 45 CFR 46, Medical terminology, Data management, Project development, Site monitoring, CRA, CRC
To obtain a position where my education and experience and previous work history would help the firm. I am knowledgeable and have worked with 21 CFR 11, 210 and 211.I was responsible for all 3rd party audits; was the responsible head for all FDA audits and responses; headed the CAPA and OOS Investigations and was involved with International Regulatory submissions as well as all FDA submissions. I was resopnsible for all OO...
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Quality Assurance, Quality Control, Manufacturing, Teaching, Bio-Statistics, Regulatory
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Project Management, Monitor, GCP-ICH, FDA, Clinical Research, Patient Safety, 21 CFR 11, Data Management, Budget and Forecast Planning
I have 14 years of experience in pharmaceutical industries. Results oriented individual with a track record of instituting and maintaining high levels of Quality Assurance and leadership. I’m seeking additional opportunities for professional development in consulting, validation, compliance or technical areas. Strong analytical and planning skills. Six Sigma Black Belt trained. Knowledge in FDA, cGMP, GLP, 21 CFR - Part 820...
Ideal Companies: Pharmaceuticals or food industries
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qa, validation, lims, qc
Quality Assurance professional with problem-solving abilities in Pharmaceutical and Biotechnology industries. Primary strengths include US (FDA) 21 CFR, and ICH Q7A Guidance for API Manufacture, Quality Systems development and implementation and strong auditing skills. Introduced and managed electronic document management software including validation, implementation, and maintenance, as well as project team leadership. R...
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Quality Assurance, FDA regulations, CAPA, Document Control, Change control
Doctor of Medicine recognized with clinical trial expertise in medical device, drug safety, regulatory affairs, and post-market monitoring. Strong emphasis on utilization of cross-functional skills to advance medical systems and develop process improvements. Results-driven collaborator with effective oral and written communication and presentation skills. Patient advocate and contributor to public health awareness and educa...
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FDA MedWatch 21 CFR 820 803, Medical Device Class III, ICD, VT / VF, Medical Affairs, Regulatory Affairs, Drug Safety, Quality Assurance and Management, Public Health, Patient Relations, Medical Communication, SAP, Excel
