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The VP QA will direct all GxP Quality activities and ensures Aveo and its vendors are inspection ready, adhere to GLP, GCP, GPV, GDP and GMP applicable regulations, company policies & procedures.
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This individual is part of DSI GMP QA organization playing an important function into Global GMP QA activities and will also serve as a delegate to represent GMP QA in other cross-functional leadership teams such as global RD/PV-QA, Global QA, Global IT, manufacturing sites and marketing authorizations holders across the organization supporting funding and enhancement for strategic expansion initiatives, training and user communication to ensure harmonization and data collection/metrics.
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Full understanding of GCP, GLP and GMP regulations and regulatory compliance guidelines. Provide QA expertise to the organization and quality oversight of the clinical trials, drug safety and translational activities.
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Working knowledge of regulatory requirements/ standards (e.g., GCP, GLP, CAP, CLIA, NYSDOH, 21 CFR Part 11). ● Serve as the GLP/GCP subject matter expert to cross-functional clinical trial teams to ensure that all quality and regulatory compliance activities were conducted in compliance with GCPs, SOPs, and ICH Guidelines.
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Conduct QA in the company’s programs, including ensuring Data Integrity in processes, data packages and reports to the Company’s external pharma and gene therapy partners. Experience in preparation and participating in inspections by the FDA is and/or other accrediting audits as may be required for GLP or GCP compliant laboratories.
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The QA Analyst will conduct biological, chemical and physical testing on pharmaceutical products (biologics and drugs) and medical devices in a GMP lab through all stages of manufacturing process from incoming raw materials to finished goods and may include some environmental monitoring programs.
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The Associate Director/Senior Manager of Clinical Quality will develop, manage, and improve existing quality systems to ensure appropriate controls for EyePoint in-house GCP and GLP capabilities.
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QA Issuance, Review and Approval of manufacturing production batch records in support of 300 BMK manufacturing operations Perform walkthroughs and other support activities of Analytical Science and Process Development to ensure compliance with applicable GMPs/GLPs. Review of GMP/GLP documentation from manufacturing and/or Analytical Operations, which can include logbooks, and test records.
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1-3 years of QA or five years of GxP regulated (GLP, GMP, GCP) industry experience; Act as QA lead for inspections at Medpace. The successful candidate will be responsible for facilitating the management of sponsor audits, broad range of regulatory inspections (FDA, EMA, MHRA) and facilitating QA relationship with external clients.
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Interface with different teams, including in vivo scientists, QC/QA, Account Managers/Sales, and the veterinary staff. Experience with GLP (Good Laboratory Practice) and non-GLP toxicology studies.
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Contribute to all aspects of laboratory work (bench chemistry, instrumental analysis, data processing, and data reduction) related to the development, optimization, and validation of analytical methods using appropriate analytical techniques (protein precipitation, liquid/liquid extraction, solid phase extraction) in combination with chromatography (GC, HPLC) instrumentation under GLP guidelines.
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Review early-stage analytical testing in support of GLP and GMP clinical protocols and production activities. Review of GMP/GLP documentation from manufacturing and/or Analytical Operations, which can include logbooks, and test records.
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QA Issuance, Review and Approval of manufacturing production batch records in support of 300 BMK manufacturing operations. Perform QA Walkthroughs for 300 BMK manufacturing product changeovers.
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Lead and manage the Pre-Clinical QA external vendor audit program for all outsourced regulated GLP toxicology, nonclinical and clinical bioanalytical, and clinical laboratories. Ensure regulated internal bioanalytical laboratories and associated functions (toxicokinetic and pharmacokinetic) meet all GLP requirements for nonclinical and clinical study sample analyses.
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The role oversees and manages the Development QA team and interacts cross-functionally with functional teams who interact with and/or support Preclinical and Clinical Trials, which include Preclinical and Clinical Operations; and, Product Development, GMP teams, Pharmacovigilance, Medical Writing, Biostatistics and Data Management to ensures compliance to the Quality Management System (QMS) and all applicable regulatory requirements.
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