CAPA Expert
- Buenos Aires
- Permanente
- Tiempo completo
Our greatest asset is our people, and nothing is more important to us than ensuring that everyone knows that. Each of our 100+ offices has its own individual identity, and each also has its own unique rewards.OverviewThe Quality Assurance (QA) Department is an independent, neutral branch of TransPerfect. The goals of the department are simple: look out for the best interests of TransPerfect and its clients and promote and improve quality. The CAPA Expert impacts all aspects of TransPerfect’s Global Quality Management System (QMS), which is compliant to all applicable international and local statutory and regulatory requirements (e.g., 21 CFR Part 11 and GCP/ICH) as well as international standards such as ISO 9001 and ISO 17100. The CAPA Expert is a specialist in all formal client-facing reports related to non-conformances documented in Compliance Report (CRs). They drive the CAPA process from start to finish with the goals of:Minimal impact to operations to pass along internal cost savingsConsistency in reporting for clientsShorter report turnaround times (TATs)Effectiveness Checks diligenceA decrease in the overall volume of CAPAs being requestedThe CAPA Expert is responsible for owning, driving and overseeing CAPAs from the time of request to client delivery and managing any post-delivery client feedback.In addition to managing CAPA reports, the CAPA Expert will also own the CAPA process overall and drive continual improvement based on its evolving needs.Job 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 impacto 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, deliveryo Follow up to ensure everything is on tracko Write the CAPA Report based on the CRso Host and lead CAPA call(s) with all relevant parties to ensure everyone agrees in the contento Ensure QA compliance and avoid any audit riskso Deliver to the client-facing POCo Maintain internal storage of CAPA Reports and associated documentationo Handle any responses to client feedback on CAPA Reports and deliver updated CAPA Reports, as neededo Attend client calls as needed to present CAPA Reporto Partner with client's QA Department to ensure client satisfactiono Track actions as promised to clients in CAPA Reports and collect/validate objective evidence of completiono Perform and oversee Effectiveness Checks to measure success of the actions upon scheduled timeframes, as neededAdditional Responsibilities:o Supporting At-Risk Client initiative including non-standard requests for trend analysis, Post-Mortems, Quality Improvement Plans (QIPs), Remediation Planso 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 supporto Routine client audit supportProcess Development:o Manage CAPA Request Form improvementso Regularly assess workflow to ensure efficiencyo Monitor initiation, tracking, and storage mechanismso Take note of training gaps and partner with L&D to mitigateo Maintain CAPA related Bookstack reference contento Track CAPA data to identify trendso 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 independentlyDesired Experience:- Participated in formal client-facing CAPA Report process- Trend/data analysis experience- Experience in root cause analysis methodologies