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Online Resumes with "ICH GMP"
regulatory affairs associate/specialist
Seeking a position in Regulatory Affairs where my skills, work ethic and achievements will be utilized to the best and which will provide me opportunities for intellectual and professional growth
Tags for this Online Resume: NDA, BLA, 510(K), ANDA, SOPS, PROTOCOLS, IND, PMA, PDP, LABELING , MEDICAL DEVICES, DIAGNOSTICS, IVD, CE MARKING, ICH,GMP,GLP,CBE-30,CBE-0, IB, SPL
Regulatory Affairs, Clinical Research, Quality Assurance
A degreed professional with over 4 years of experience in the pharmaceutical/Biotech industry with multi-functional Regulatory, Clinical and Quality background. Demonstrated ability to expand beyond the scope of assigned responsibilities to gain proficiency in new areas. Responsibilities have ranged from managing the preparation, submission of INDs, BLAs, ANDAs/NDA, to reviewing QMS, essential regulatory documents to ensure...
Tags for this Online Resume: Regulatory Affairs, Clinical Research, FDA, GCP, GCP, ICH, GLP, Pharmaceuticals, Quality Assurance
Clinical Quality Assurance - 20 Years of Experience - Near 94403
QA/QC experience working with FDA ICH and Japanese regulations 21 CFR reviewing Writing editing submission documentation SOPs Protocols Reports. Product/Project analytical requirements evaluation budget in-house vs. out-source estimation. Upgrading of R&D laboratories to GLP/GMP level.
Ideal Companies: small start-up company
Tags for this Online Resume: methods transfer validation, phase I, II, III protocols and reports, GMP GLP, Laboratory management, hiring training budgeting, FDA ICH regulations, validation monitoring transfer, medical devices, Consulting, Document Review, Documentation, DSC, High Performance Liquid Chromatography (HPLC)
