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Online Resumes with "Analytical method Validation"
Summary of Experience William H, Fleming, III, PhD has thirty five plus years in the plasma, biopharmaceutical, medical device, contract manufacturing and hospital based clinical industries. He specializes in operations management and quality systems for active pharmaceutical ingredients, finished plasma derived drug products, medical devices, small molecule sustained release microsphere based drug products, biological prod...
Tags for this Online Resume: Regulatory Compliance, Regulatory Affairs, Regulatory Compliance Auditing, Analytical Chemistry, Method Validation, Process Validation, Microbiology, Standard Operating Procedures, CMC BLA 510K, Policies and Procedures
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...
Tags for this Online Resume: Reviews, Chemistry, CMOS, Compliance, Documentation, Drafting, Product Development, Security, Systems Development, High Performance Liquid Chromatography (HPLC), pharmaceutical
Work as a team with pharmaceutical company as a senior level analytical research scientist.
SUMMARY OF QUALIFICATION An accomplished research professional with excellent communication skills who is organized, detail oriented and a team player. Has over 21 years of experience and extensive background that includes leadership role in analytical research in many reputed pharmaceutical organizations. KEY AREA OF EXPERTISE Lead and supervised a team of scientists to execute analytical method development, method validat...
Tags for this Online Resume: DSC, Emerging Markets, High Performance Liquid Chromatography (HPLC), Spectrophotometer, Management, Engineering, Reverse Engineering, Accounting, CFR Part 11, Cost Accounting
Life cycle Management and documentation of specification in Laboratory Information Management Systems (LabWare LIMS) in cGMP environment. * Create and Manage Drug substance, Drug product, and Raw materials specifications in LIMS against the master specification copy available in the Document management system. * Accurately configure Analysis's including Strength, Impurities content, Water content, Content uniformity, Resid...
Tags for this Online Resume: Acceptance Testing, Audit, Configure, Document Management, Documentation, Good Manufacturing Practices, High Performance Liquid Chromatography (HPLC), Management, Manufacturing, Pharmaceutical Industry
Well experienced in Medical Device Industry as Equipment Validation / Quality Engineer with strong background in New Product Development, Equipment Qualification, Manufacturing, Packaging, Process and Test Method Validation. * Good experience in analytical method validation using statistical tools. * Expertise and experience in developing and implementing Master Validation Plan (MVP), and in using six sigma tools like FMEA...