Early Access Program Quality Assurance Consultant

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    "requisitionDescription": "<p style=\"margin-left:0in;\" data-pasted=\"true\"><strong><br></strong>The Early Access Program (EAP) QA contractor will provide comprehensive, hands-on Quality Assurance (QA) Management and Compliance services for Savara&rsquo;s EAP, including post-trial access, compassionate use, and named patient programs, to provide eligible patients with access to investigational therapy. This person will work cross-functionally and with external EAP vendors. This role is a consultant (1099), expected to work ~140-170 hours/month for 12 months.</p><ul type=\"disc\"><li style=\"margin-left:0in;\">Provide QA GCP oversight of service providers/program(s), ensuring compliance with SOP, GCP, ICH and regulatory requirements</li><li style=\"margin-left:0in;\">Identify quality/compliance issues, perform risk assessment, escalate potential risk/issues and actively resolve with key stakeholders</li><li style=\"margin-left:0in;\">Serve as QA lead for program related deviations, working with stakeholders to investigate/resolve, identify root cause, and implement appropriate CAPA&rsquo;s along with effectiveness checks</li><li style=\"margin-left:0in;\">Partner with service providers and clinical operations to manage on-time deliverables</li><li style=\"margin-left:0in;\">Plan, conduct, and/or assist with service provider and site audits as needed based on program requirements</li><li style=\"margin-left:0in;\">Perform quality review for program related documentation (i.e., protocol, informed consent, labelling, etc.)</li><li style=\"margin-left:0in;\">Support program related regulatory filings by ensuring correct and accurate information</li><li style=\"margin-left:0in;\">Review executed packaging/labelling records and QP batch certification as well as perform final disposition of finished product in accordance with Savara procedures</li><li style=\"margin-left:0in;\">Extensive understanding and knowledge of QA GCP, GMP and GVP regulations, industry standards, concepts and other health standards/guidance&rsquo;s related to Quality Systems and Quality Assurance is required</li></ul>\n",
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