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Strong knowledge of FDA, EU, ICH GMP regulations and guidelines, with expertise in interpreting and implementing quality systems for GxP applications in a practical manner. Lead eQMS changes and process improvements to enhance efficiency, effectiveness, and compliance with evolving GMP regulations.
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Knowledge of GMP (Good Manufacturing Practice) and GCP (Good Clinical Practice). Our team is proficient in various areas, including Clinical Data Management, Regulatory Submissions, Biostatistics, Statistical Programming, Data Analytics, and PK/PD analysis.
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Job Title: GMP Business Analyst. SAP Fiori App integration. Plant Maintenance Master Data: Equipment/Functional Location/Maintenance. Able to create SAP reports from Plant Maintenance Master Data.
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Plans/Strategy/Scheduling Overview/Material Inspection Characteristics/Catalog and Groups/Main Work Centers/Confirmation and Technicians Actuals/Report Writing in SAP/Material Master and FHMI and ERSA types/Measurement reading transfer and counters/Mobile Maintenance/Analytics/Embedded Analytics.
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This is an incredible opportunity to assist pharmaceutical and biopharmaceutical companies in driving quality; help our clients manage and prepare for FDA GMP inspections and manage post inspection activities; and work alongside some of the best and most experienced regulatory compliance professionals.
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1 - 2 years previous experience in a GMP laboratory desired; internship experience considered. The QC Microbiologist I, Environmental Monitoring will learn, understand, and perform routine entry level sampling of cleanrooms and utilities according to written procedures under cGMP conditions; as well as tasks involved with clerical and logistical laboratory tasks.
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Utility sampling of RODI/WFI water systems (collect Bioburden and Endotoxin samples for testing) in accordance with approved methods. Sampling of incoming raw materials as needed (i.e. Sodium Hyaluronic Acid Powder.
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Knowledge of GMP, GLP and GCP regulations and clear understanding of the pharmaceutical product life cycle. Interface with external Regulatory Operations vendor to support submissions to FDA. Knowledge of GMP, GLP and GCP regulations and clear understanding of the pharmaceutical product life cycle.
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We are seeking a highly skilled and detail-oriented GMP Test Technician to join our team. The GMP Test Technician will play a crucial role in maintaining the highest standards of quality assurance in a regulated manufacturing environment.
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Proven experience as a GMP Test Technician or similar role in a regulated manufacturing environment. Identify opportunities for process improvement and efficiency in GMP testing procedures.
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Three years (3) Experience with Quality Systems and GMP Regulations, specifically complaint investigations. Start Your Week on a High Note: Indulge in our "Bagel Tuesday" perk, where you can enjoy a fresh bagel on us every Tuesday morning.
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Working knowledge of GMP and FDA regulatory requirements for Class III medical devices or equivalent. Working knowledge of GMP and FDA regulatory requirements for Class III medical devices or equivalent.
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Qualifications Strong Knowledge of SMT Processes, equipment, and industry best practices Working knowledge of basic printed circuit board design and concepts Working Knowledge of GMP and ISO requirements.
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Azzur COD is looking for a GMP Facility Manager. GMP experience in preferred. Including HVAC, Gases, Liquid Nitrogen, Tower Water, Heating Hot Water, Refrigerated Water, Etc. This employee will be a Cleanrooms On-Demand Burlington business unit (Facility Solutions) leader, who will be responsible for employees supporting the facility, client start-up, and continuous business improvement at COD. The Facility Manager will perform repairs, Maintenance, and improvement within cGMP cleanrooms, Laboratory, Warehouse, and office spaces.
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For example, of hands-on activities, they must be comfortable and capable writing/drafting/editing GMP docs and guiding on-floor operation, etc. Provide expertise on GMP, lean operations, operational fit and efficient production scheduling as the designated Technical Lead for facility start-up or New Product Introduction projects.
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gmp job Company: Genoskin in Burlington, MA
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