水平: Mid-Senior level
工作类型: Full-time
工作内容
Manage and oversee the development and implementation of Quality Assurance (QA) procedures, processes and standards to ensure alignment to global quality policy and local regulatory guidelinesDraft, review or revise SOPs to assess consistency and compliance with regulatory requirements/internal standards and business needsAttend cross-functional team meetings and provide guidance to clinical and internal operations staff based on interpretation of current regulations to ensure best practices including risk-based managementWork closely with the patient support operations personnel to ensure/coordinate appropriate and complete resolution of findings/non-compliant issues, quality investigations, etc. in a timely manner, including approval of corrective action and preventative action (CAPA) plans, as necessaryConduct and/or assist in internal audits (systems, processes, vendors, computer system validation)Identify the need for, conduct and/or assist in external audits (includes, but is not limited to, investigator sites) and review related audit documentsOversee the audit response process for the Investigator Site audits/inspections and ensure acceptability of actions to address findings through the CAPA processReply the Due Diligence or related Questionnaire from pharmaceutical clients and complete internal review processBased on SOPs and program process to provide monthly Quality Control (QC) review and monitoring of each program to the Patient Solutions ManagerConduct QA training within sales teamPerform program specific root cause analysis of compliance issues and provide the appropriate metrics for tracking and trending for the overall QA reporting requirements to the Patient Solutions ManagerAssist with inspection readiness, and regulatory inspections as needed
最后期限: 20-12-2024