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Online Resumes with "FDA Inspections"
At this stage of my career, I am looking for a change in direction that will be both challenging and rewarding. An entry level pharma/medical device sales position is just the sort of thing that I am looking for.
At this time I would like to be a consultant or a temperary position to pharmaceutical companies for their quality or R&D problums. I have experience in dealing with FDA related issues in durg discovery and production. I can help the starter company to build up their quality system and train their employees to comply with the cGMP requirements by FDA. I do not mind to travel. I can speak, read and write Chinese in addition ...
Ideal Companies: Any company which can use my experience
Tags for this Online Resume: Qhality Assurance, QA, cGMP, FDA, ICH, Q7A, Inspection, Audit, Deviation Report, Change Control, OOS Report, Annual Report, DMF, validation, Purified Water, FDA Inspection
Contribute to the overall success of progressive company providing the best service through innovation, team work and continues improvement process.
As an established Quality Control Manager, I have extensive experience in quality assurance, instrument qualification, procedure writing, analytical methods development, transfer and validation. I Possess expertise with FDA, ICH and EU requirements for pharmaceutical, drug substance, drug product and device testing. I Collaborate effectively with outside vendors and internal groups including assay development, manufacturing...
QC Lab Supervisor using skills as an Analytical chemist.
Ideal Companies: A company that can use my managerial skills and laboratory expertise.
Tags for this Online Resume: chemist
In charge of corporate quality and regulatory affairs function in Asia Pacific Region of international giant pharmaceutical or biotech companies. English and Chinese-speaking countries. GXPs experts. Registrations, audits, trainings.
Tags for this Online Resume: Regulatory Head, Quality Compliance, Asia, China, Pharmaceutical, Bioteh, Quality and Regulatory Compliance, Inspection, , Pharmaceutical/Bioteh/Medical Device Industry, FDA Quality and Regulatory Compliance, , FDA Inspection, US/EU Market, US/Asia Mobile, Lifecycle Total Management, US/Asia Mobile for Job Locations, 30+ years Experience in FDA Regulated Industry
My range of experience began with hands-on work testing and measuring products, and I then went on to supervision and documentation. When I moved into a corporate role I became an expert on administration of Quality Systems and Documentation Systems, adapting this infrastructure to address new product classifications, new manufacturing sites, and new regulatory requirements. I was responsible for monitoring regulatory chan...
Extremely loyal, detail orientated individual with the ability to multitask as well as work well with others with or without supervision.
I have been working in the Biotechnology industry for the last 9 years in the Pharmacokinetics & Drug Metabolism group at Amgen. I worked to characterize the pharmacokinetics (PK), pharmacokinetics/pharmacodynamics (PK/PD), and metabolic fate of novel drug candidates using state-of-the-art procedures and technologies. I supported discovery from research into the clinical. I developed and validated analytical methods whic...
I am a senior management professional with over 20 years of management experience. I have specialized in taking start-up or take-over situations and turned them into successful enterprises. I have managed from 1-45 stores at any given time.
Distribution Center Manager with extensive experience in operating buildings up to 1.3 million square feet that included 8 managers, 40 supervisors and 600 employees. Demonstrated talent for starting up large scale distribution centers, implementing warehouse management systems, stabilizing operations, establishing metrics and implementing inventory control processes. Aspire to the lead the logistics and distribution for a ...
Skilled in the planning and implementation of clinical research projects in compliance with ICH-GCP, Regulatory Agencies, and company SOP. Study Start up expert. Proficient in Microsoft Office Applications, CTMS, IVRS/IWRS, INFORM, Medidata Rave. Therapeutic areas: Oncology, Cardiology, Neuroscience, Internal Medicine, including Diabetes. Participated in 3 FDA Submissions, FDA Inspection Readiness and TMF reconciliation