SUMMARY OF QUALIFICATION * Extensive experience in FDA regulatory requirements (GMP, CFR) and ISO standard regarding Medical Device, Pharmaceutical, Skin Care, and Food Industry * Extensive experience Lean Quality Tools (FMEA, Pareto Charts, Fishbone Diagrams, Six Sigma 5S, and SPC to assure efficient process and high product quality product * Extensive experience in managing the Supplier/ Vendor qualification program, Supp...
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Extensive experience in CAPA, Extensive experience in IQ/OQ/PQ VAlidation, Extensive experience Quality audit, Extensive experience Supplier Qualification, Extensive experience FDA and ISO Regulatory, Extensive experience Process and Quality improvement, Extensive experience Reducing customer complaint, Scheduling, Chemistry, Good Manufacturing Practices
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Quality, Quality Assurance, Quality Control, Compliance, Electrophoresis, ELISA, Good Laboratory Practices, HIV, Management, Medical, FDA Guidelines, GCP Guidelines, Regulatory Documents, Cardiovascular Clinical Research, Oncology Clinical Research
Qualification Highly motivated and accomplished Clinical Research Coordinator with extensive skills and experience. Nine years of experience as an Oncology research coordinator. Proven ability to manage multiple studies simultaneously. Managed phase 1b - IV protocols according to GCP and FDA guidelines. Experience as a supervisor and mentor to study coordinators across various oncology disease sites. Trained staff on study ...
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Appraisals, Audit, Clinical Research, Data Quality, Documentation, Management, Protocol, Quality, Quality Assurance, Recruiting
To obtain a challenging position in pharmaceutical industry involved in drug discovery and quality control that takes advantage of my experience in medicinal chemistry, organic synthesis and analytical laboratory skills. Willing to make an impact for the success and growth of a cutting edge company by utilizing my skills and experience. Professional Summary: * Experienced in medicinal chemistry, organic synthesis and qualit...
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Chemistry, Research, Sar
SUMMARY OF QUALIFICATIONS QUALITY CONTROL/QUALITY ASSURANCE MANAGER with extensive experience in analyzing and solving product and process related problems. Proven ability to use innovative approaches to proactively develop efficient, cost saving solutions to problems in a variety of work environments. Easily establish rapport with co-workers and department managers to accomplish goals. Successfully achieved and exceeded co...
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Quality Assurance, Quality Control, Process Control, Scheduling, Test, Training, Troubleshooting, Six Sigma Black Belt
Experienced with trouble shooting issues in chromatography and other testing procedures resulting in effective and high quality test methods * Maintained daily, weekly, and quarterly checks of instrumentation such as stability chambers and HPLC systems as part of team responsibilities, reducing the need for a separate metrology group Scientist II (Laboratory Technical Services) 2011 Performed remediation activities for exis...
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Filing, Forth Programming Language, Quality Assurance, Regulatory Affairs, Test, High Performance Liquid Chromatography (HPLC), Instrumentation, Quality, Quality Control, Compliance, pharmaceutical, sop, change control, method validation, cleaning validation, hplc, fda, raw material, in-process testing, finished product, solid dose, research and development, method transfer, protocol, report
PROFESSIONAL SUMMARY * Over 8 years of experience in Information Technology field with strong emphasis in SAS Application Analyst/ Programmer with 3+ years of hands on experience and professional experience in Clinical Trial projects and also worked as Application Analyst in the CROs, Healthcare and Pharmaceutical industries. * Experience in analyzing and coordinating clinical data, generating detail summary reports and dat...
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Management, Oracle, Oracle 9i, Information Technology, Process Improvements, Coding, Health Care Industry, HyperText Markup Language, Manufacturing, sql, SAS analyst
QUALIFICATIONS SUMMARY * cGMP quality management experience [ QA/QC and RA]. QA experience with quality management systems (QMS) and documentation, batch record reviews, annual product reviews, SOP drafting, review and approve, investigate deviation, change and document control. Established key performance indicators (KPIs), quality by design (QbD) process analytical technology (PAT) and Quality metrics. Experienced with de...
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Reviews, Chemistry, CMOS, Compliance, Documentation, Drafting, Product Development, Security, Systems Development, High Performance Liquid Chromatography (HPLC), pharmaceutical
