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Ability to interact successfully with internal and external stakeholders including Clinical Development, Regulatory Affairs , Drug Safety and Pharmacovigilance, Legal , Commercial, Sales and Marketing, etc.
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GCP, and GLP Quality Systems responsibilities include training, document management (SOPs and other controlled documents), change control, process improvement, and quality Quality systems activities will be coordinated with the Quality Systems group.
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The Director of Quality Systems and Compliance is responsible for CGMP Quality Systems and Compliance of the facility inclusive of Deviations, CAPA, Change Control, Complaints, Quality Management Review, Supplier Quality, Audits, Inspections, Document Management, Learning Management, APQR, Regulatory Affairs, and Compliance.
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Charter cross functional tech transfer teams comprising of R&D, QA, QC, Regulatory Affairs, and operations. Responsible for developing process control strategy document, technology transfer change controls, engineering, clinical, and PPQ batch protocols in coordination with R&D and ensuring that the manufacturing batch record meets established conditions as defined in the CMC documentation.
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5) Charter cross-functional tech transfer teams comprising of R&D, QA, QC, Regulatory Affairs, and operations. 12) Oversee product technical lifecycle management with regards to process control strategy process/yield improvement, process knowledge management, batch deviations, and ensure accuracy of regulatory CMC registration detail.
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Work with QC, QA, Supply Chain, Analytical Development, Process Development, Manufacturing, Manufacturing Technical Service, Regulatory Affairs, and CMOs. Facilitate major investigations, review of change control requests, provide representation to tech transfer as needed, review of process and method validation initiatives in support of the QC laboratories in the.
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Responsibilities: Project Management (%) Technical writing-author and review of protocols, reports, data summaries, procedures, etc (%) Lead analytical method qualification and validation studies (%) Support with Training personnel as required (%)Work with QC, QA, Supply Chain, Analytical Development, Process Development, Manufacturing, Manufacturing Technical Service, Regulatory Affairs, and CMOs.
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A first line of defense risk professional within the Governance and Controls Office (GCO) for Human Resources, the Government Affairs and Legal Team, and Office of Chief of Staff, responsible for the execution and support of various risk programs including but not limited to the risk control self-assessment (RCSA), business and regulatory change initiatives, issues management, loss events, third party, model risk, data risk and cyber risk.
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Job Description PharmaLex is one of the largest worldwide providers of consulting services in the following focus areas: Quality Management & Compliance; Development Consulting & Scientific Affairs; Regulatory Affairs; and Pharmacovigilance, Epidemiology and Risk Management.
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Knowledge of cGMP, Quality Systems (CAPA, Investigations, Complaints, Change Control), Drug Regulatory Affairs, manufacturing and packaging processes required. Maintains Investigation, CAPA, Complaints, Change Control systems logs.
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Provides consultation/advice to regulatory specialist for change control and product development. The position of Regulatory Affairs Specialist II is within our Infectious Disease business unit.
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Authors and s upports regulatory submissions, regulatory operations, change control, lifecycle management, interactions with regulatory agencies/Notified Bodies, technical file/design dossier management and approval of Declaration of Conformity as applicable.
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The Regulatory Affairs Specialist will support the development of submissions for domestic and international clearances for spine surgery products; as well as the support of daily activities related to product design teams, change control, and regulatory product submissions.
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Must have technical knowledge on the use of QMS systems (Documents, Training, Deviation, Change Control, CAPA) 5+ years of work experience in Quality Assurance or Regulatory Affairs in a cGMP pharmaceutical and/or biological manufacturing regulated environment preferred.
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Support the Quality group's oversight efforts with quality systems such as change control, quality investigations, CAPA identification and resolution, audits, and any other recommendations to compliance issues and/or observations as they arise.
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regulatory affairs change control jobs
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