CAPA Expert

1 semana atrás

São Paulo, Brasil TransPerfect Tempo inteiro

Description :CAPA Report Management: o Initial intake to determine if a CAPA Report is in fact warranted and appropriate based on the severity of error and its impact o Preflight of CAPA requests to survey the client relationship and type of report needed (NTF, NC, CAPA) o Ensure all relevant CRs are properly documented in TransPerfect’s Quality Management System (QMS) (ProjectA) o Create an internal schedule for CR investigation(s), approval(s), drafting, delivery o Follow up to ensure everything is on track o Write the CAPA Report based on the CRs o Host and lead CAPA call(s) with all relevant parties to ensure everyone agrees in the content o Ensure QA compliance and avoid any audit risks o Deliver to the client-facing POC o Maintain internal storage of CAPA Reports and associated documentation o Handle any responses to client feedback on CAPA Reports and deliver updated CAPA Reports, as needed o Attend client calls as needed to present CAPA Report o Partner with client's QA Department to ensure client satisfaction o Track actions as promised to clients in CAPA Reports and collect/validate objective evidence of completion o Perform and oversee Effectiveness Checks to measure success of the actions upon scheduled timeframes, as needed Additional Responsibilities: o Supporting At-Risk Client initiative including non-standard requests for trend analysis, Post-Mortems, Quality Improvement Plans (QIPs), Remediation Plans o Routine client-facing CR reporting outside of formal CAPAs (e.g., Excel format) o QA-to-QA client partnerships including routine meetings, reporting on Key Quality Indicators (KQIs), reviewing Quality Assurance Agreements (QAAs) o Client QBR Meeting support o Routine client audit support Process Development: o Manage CAPA Request Form improvements o Regularly assess workflow to ensure efficiency o Monitor initiation, tracking, and storage mechanisms o Take note of training gaps and partner with L&D to mitigate o Maintain CAPA related Bookstack reference content o Track CAPA data to identify trends o Decrease the overall volume of CAPA reports being requested by 1) driving down frequency of critical issues, 2) educating client-facing POCs on how to solve issues without offering/promising a formal report to clients (e.g. informally reporting back on CR investigations via email, meetings, calls, QBRs, etc.) Complete all other tasks that are deemed appropriate for the role and assigned by the manager/supervisor. Required Qualifications & Experience: - Minimum Bachelor’s degree or its equivalent - Minimum 2-3 years’ experience - Experience in complaint handling - Fluency in English (written and verbal) Required Skills: - Main Investigator and/or Manager/Sales Approver on Compliance Reports (CRs) within Quality Management System (ProjectA) - Excellent writing skills and knowledge of appropriate client language - Excellent organization skills and the ability to self-monitor and efficiently handle and prioritize tasks - Clear communication skills including delegation of tasks - A consistent positive and professional attitude and the desire to contribute to the CAPA culture - Natural leadership in calls/meetings - Exceptional problem solving and critical thinking - Deadline oriented - A desire to continually improve and the ability to take initiative independently Desired Experience: - Participated in formal client-facing CAPA Report process - Trend/data analysis experience - Experience in root cause analysis methodologies

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