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The Clinical Systems Analyst will assist the Senior Director of Clinical and Development Systems in planning, directing, and coordinating software projects and support activities within the Drug Safety, Pharmacovigilance, Regulatory, Clinical Operations, and Quality Assurance groups.
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3-5 years of experience in drug safety, pharmacovigilance, quality assurance, or a related field. This role requires a strong leader with a deep understanding of commercial patient services, pharmacovigilance, quality assurance, and regulatory compliance.
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A background of pharmaceutical manufacturing or quality control/quality assurance is a plus. The CMC Regulatory Technical Writer II authors high quality Module 2 and 3 regulatory submissions for both development and post-approval dossiers, change controls and technical reports.
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Global Pharmaceutical company, with US HQ in Central New Jersey, focused in Metabolics, Endocrinology and Oncology is expandingLooking for a strong Quality Assurance Manager for the entire North American manufacturing and quality organization.
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In addition, this role will perform critical quality assurance activities such as Change Management, SOP Management, and Audit oversight. Experience with Veeva (Quality Docs, QMS and Training modules) a plus.
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Position requires on-site presence at companies' HQ Essential Duties and Responsibilities Conducting Training: Developing and conducting training programs for personnel on GMP and GDP requirements, quality systems, and relevant procedures to ensure understanding and compliance throughout the organization.
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Developing and Maintaining Quality Systems: Establishing and maintaining comprehensive quality systems in compliance with GMP and GDP regulations. Continuous Improvement Initiatives: Leading or participating in continuous improvement initiatives to enhance the effectiveness and efficiency of quality systems and processes, driving a culture of quality and excellence within the organization.
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Experience in Quality Assurance/ Quality Systems related to cell therapy manufacturing in commercial setting. Minimum 4 years of relevant work experience with Quality Assurance Systems or Quality Assurance Investigations.
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Quality Risk Management: Implementing quality risk management processes to identify, assess, and mitigate risks to product quality, patient safety, and regulatory compliance throughout the product lifecycle.
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Managing Supplier and Vendor Quality: Assessing and approving suppliers and vendors based on their adherence to GMP and GDP standards. Reporting and Tracking: Providing internal customers with status reports, inspection results, improvement updates and other KPI and regulatory/quality required reporting.
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Supporting Validation Activities: Providing quality oversight and support for validation activities, including process validation, equipment qualification, analytical method validation, and cleaning validation, to ensure compliance with regulatory requirements.
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Performs quality assurance testing, and acquires and records all parameters needed to deliver radiation therapy accurately, using policies, practice standards, prescriptions and professional judgment to ensure quality with regard to all aspects of treatment delivery.
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Knowledge or certifications in Software Quality Assurance and Software Quality Engineering. The Lead, Infrastructure Assurance will provide quality oversight within the Tools and Infrastructure space.
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Top Tier BioPharmaceutical company looking to add a Principal Scientist to their dynamic Pharmacometrics team.
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The Senior Manager also develops and establishes Quality Assurance testing methods with IT Operations, including automated regression test methods and tools using the golden dataset concept.
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