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Withum's Forensic and Valuation Services practice pride themselves in understanding their clients' business strategy and needs; assisting companies in meeting business requirements related to valuation, risk management, transfer pricing, economic analysis, and model validation.
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Ranked the overall #4 Best Civil Engineering Firm to Work for in the Nation (#1 in our size category) and residing on the list of the Engineering News Record (ENR)’s Top 500 Design Firms in the nation, TPD (Traffic Planning and Design, Inc.) is currently hiring a Civil Engineer for design projects in New Jersey and Pennsylvania.
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To provide oversight and guidance to ensure the eTMF system aligns with Eisai TMF vision and transformation initiative and is compliant with ICH-GCP and regulatory requirements. This includes overseeing the daily global eTMF system related activities relating to clinical study Trial Master Files (TMF), ensuring regulatory inspection-readiness and compliance with applicable laws and regulations.
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Keywords: Android, middleware, libraries, Jetpack Compose, Kotlin, threading, software engineer, developer tools. As a Software Engineer, you will play a pivotal role in crafting innovative and efficient Android middleware libraries that empower developers to build exceptional user experiences.
$140,000 a yearFull-timeExpandApply NowActive JobUpdated 16 days ago - UpvoteDownvoteShare Job
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Equipment validation (bioreactor IOQ and PQ study, but not limited to the other cell culture validation activity). Familiar with stainless steel vessel operation with DCS control (Medium Preparation, CIP/SIP.
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This includes Complaint Handling, Adverse Event Reporting, Health Hazard Evaluations (HHEs), Field Actions, and Post Market Surveillance activities required for EU MDR and other global regulatory bodies.
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Key internal relationships include brand marketing, market access, commercial effectiveness, sales, medical/CMR, legal, compliance, and regulatory. Must have solid understanding of the pharmaceutical marketplace including legal, medical, regulatory and clinical processes.
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Determine appropriate corrective and/or preventative Perform trending of the root direct causes/ root causes of events and deviations, and issue reports to DPCM Leadership We are looking to recruit a Candidate: A minimum of BSc in Chemical Engineering and a minimum of 1 to 3 years of industrial experience in either a chemical or pharmaceutical environment, as a process engineer in a manufacturing facility performing the various aspects of a Process Engineering role.
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Validating equipment and processes, including bioreactor Installation Qualification (IOQ) and Performance Qualification (PQ) studies, and other cell culture validation activities. Familiarity with stainless steel vessel operations with Distributed Control System (DCS) control, including medium preparation and CIP/SIP.
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As a Senior Data Engineer in Research IT, you will play a critical role in supporting Research Foundational Data Products including CoreReg, Substance Mart, DARE and Asset Mart. You will be responsible for designing, developing, and maintaining data pipelines, ensuring data quality, and enabling data-driven decision-making processes.
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The QA Associate shall assure compliance with all standards and regulatory guidelines. Participate in the execution of validation and process improvement activities. Perform cleaning verification/validation swabbing of equipment.
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Minimum of 8+ years of industry experience within Regulatory Affairs CMC, with a strong understanding of compliance and biologics. The project portfolio at Genmab is evolving, and we are therefore looking for a Director/Associate Director to join the Regulatory Affairs CMC team.
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The Wound Care RN manages, organizes, and provides follow up care in collaboration with the Nurse Practitioners for Restore First Health in accordance with applicable federal, state, regulatory, and company standards to ensure the delivery of quality patient care is rendered at all times, and that the Plan of Care and physician orders are followed with regard to established clinical protocols.
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Aware of Joint Commission, CMS, DOH and other regulatory standards to support patient care. She/he functions as in-house administrator utilizing the hospital administrator as needed for consultation.
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Knowledge of key concepts including unit operations, processes, quality by design (QbD), tech transfer, process validation, quality attributes, and regulatory milestones across pharma development.
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validation engineer regulatory jobs in Princeton, NJ
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