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Supportare i dipartimenti di Pharmaceutical Development e Drug Substance Development per gli aspetti GMP. Valutare i Quality Agreement di fornitori GMP. Verificare protocolli e report GMP.
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External US About This Role The Associate Director for DPM is responsible for executing GMP readiness and preparing for the operation of the new facility to support customer onboarding. Join FDB and help manufacture the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe.
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Experience working with SOPs, GDP, GMP, CLIA, and the FDA. BioLife Plasma Services is a subsidiary of Takeda Pharmaceutical Company Ltd. That’s how we tackle rare disease. By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s and.
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Adhere to GLP and GMP guidelines as required to maintain a compliant, safe and clean work environment. Adhere to GLP and GMP guidelines as required to maintain a compliant, safe and clean work environment.
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Establish and maintain key stakeholder relationships, to understand and assist with their needsEnsure installations are assessed for quality and that they are GMP compliantAlign with CQV and Construction on System boundaries and have input into review exercise on Clean Utility direct impacting systems.
$65,000 - $85,000 a yearFull-timeExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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Oversee future validation efforts associated with the operation of all GMP manufacturing systems, equipment and computer systems. Managing Quality Engineering and Validation (QEV) Validation programs for the facilities, utilities, manufacturing and QC lab equipment, computerized systems and associated processes.
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Bioburden, Endotoxin, GMP, Microbiology, quality control, Laboratory, biology. The vaccine manufacturing capabilities center on large-scale microbial fermentation, purification, conjugation and cell banking.
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The QC LIMS Sr. Specialist 1 works closely with Quality Control, Analytical Development, Manufacturing and Quality Assurance to ensure compliance with GMP requirements. The QC LIMS Sr. Specialist 1 works closely with Quality Control, Analytical Development, Manufacturing and Quality Assurance to ensure compliance with GMP requirements.
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Additionally, there will be interim responsibilities associated with a large greenfield start-up, including international travel, performing system user acceptance testing, and setting up the dispensary area for GMP operations.
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Advises internal teams on the application of drug and device laws and regulations, as well as Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP) and Good Pharmacoepidemiology Practice (GPP) as well as Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP) as they relate to clinical research.
Full-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Direct knowledge of design and troubleshooting with GMP Biopharmaceutical Production facility equipment/systems such as cell culture reactors, centrifugation, chromatography, tangential flow filtration, single use systems as well as other equipment needed to support these processes such as autoclaves, clean in place (CIP) systems, washers, clean steam, water for injection, etc.
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The Metrology Engineer position involves a range of responsibilities within a GLP/GMP environment. Experience - 4+ years’ experience within a GLP/GMP Environment, laboratory experience. Must be familiar with basic GLP/GMP policies and guidelines and understand how their role impacts.
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Participates in managing the budgets and estimates at various stages of each project and helps to maintain Master Budget Template, GMP Estimate Roll-Up, and cost guidance models for various key project inputs.
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3+ years of experience in GMP Quality Assurance and/or similar role. 3+ years of experience in GMP Quality Assurance and/or similar role. Understanding of cell culture, upstream processes, large scale recovery and/or downstream processes.
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3+ years' experience working in a cGMP Quality Control department or in a FDA regulated industry (drugs/biologics) Configures basic and advanced LabWare LIMS objects including, but not limited to: Specifications, Analyses, Batch Templates, Test list, QC samples, Calculations, Format Calculations and Various Templates (Stability, Sample Login, Standards and Reagents.
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