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5+ years’ experience in GMP Quality or Manufacturing in biopharma/biologics/pharma industry. – Provide guidance, advice, and support for GMP quality and compliance. Thorough knowledge of GMP regulations; direct interaction with FDA, EMA or other regulatory agencies during regulatory inspections is a plus; direct interaction with qualified person (QP) is a plus.
ExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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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.
ExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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Strong understanding of GxP/GMP/CSV framework and software validation requirements. As the IT Lead at US headquarters in Raleigh, NC, this pivotal role oversees the design, deployment, and leadership of information systems and technologies focused on new Cell & Gene Therapy Center of Excellence in Research Triangle Park (RTP.
ExpandApply NowActive JobUpdated 11 days ago - UpvoteDownvoteShare Job
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The Metrology Compliance Specialist supports the Metrology Services Department as a part of a rapidly expanding GMP Manufacturing Operation. Additional duties include the writing, review, approval, and maintenance of GMP and non-GMP documentation including Standard Operating Procedures (SOPs), Non-Conformance reports, and calibration records.
ExpandApply NowActive JobUpdated 19 days ago - UpvoteDownvoteShare Job
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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.
ExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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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.
InternExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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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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Experience in other GxP areas (GLP, GVP, GMP, GDP) is an asset. Independently plan, coordinate and execute quality activities (e.g. data review, spot checks) in accordance with the risk mitigation plans to validate the systems and processes established to ensure subject safety and protection and to ensure that clinical trials are performed and data are generated in adherence with the study protocol, targeted endpoints and in compliance with regulations.
Full-timeExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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Oversight of the project team's compliance to critical Owner contract terms and conditions, namely contract price/GMP and contract time parameters to ensure project teams and protecting our interest and risks.
$110,000 - $170,000Full-timeExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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Sterile compounding or GMP aseptic manufacturing experience is preferred. Sterile compounding or GMP aseptic manufacturing experience is preferred. We provide specialty sterile and non-sterile preparations for unique patient needs, across most medical practice categories and veterinary medicine.
Full-timeExpandApply NowActive JobUpdated 8 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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The Manufacturing Operations Associate II will be responsible for processes, cultures, cryopreserves, and otherwise manipulates cell products using aseptic techniques, according to written Standard Operating procedures, in accordance with facility GMP and GLP practices.
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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.
Full-timeExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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Establish a robust QA compliance framework for GMP adherence. 10-15 years of experience in pharmaceutical/biotech industry, including drug substance/drug product manufacture, development, and/or quality.
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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.
ExpandApply NowActive JobUpdated 8 days ago
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