Corrective and Preventive Action Expert

Overview

Join to apply for the Corrective and Preventive Action Expert role at TransPerfect .

The 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 with 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 specializes in formal client-facing reports related to non-conformances documented in Compliance Reports (CRs). They drive the CAPA process from start to finish with the goals of:

• Minimal impact to operations to pass along internal cost savings
• Consistency in reporting for clients
• Shorter report turnaround times (TATs)
• A decrease in the overall volume of CAPAs being requested
• Owning, driving and overseeing CAPAs from the time of request to client delivery and managing any post-delivery client feedback
• Owning the CAPA process overall and driving continual improvement based on evolving needs

CAPA Report Management

• Initial intake to determine if a CAPA Report is warranted and appropriate based on severity and impact
• Preflight CAPA requests to survey the client relationship and type of report needed (NTF, NC, CAPA)
• Ensure all relevant CRs are properly documented in the QMS
• Create an internal schedule for CR investigation, approval, drafting, and delivery
• Follow up to ensure everything is on track
• Write the CAPA Report based on the CRs
• Host and lead CAPA calls with relevant parties to ensure alignment on content
• Ensure QA compliance and avoid audit risks
• Deliver the CAPA Report to the client-facing point of contact
• Maintain internal storage of CAPA Reports and associated documentation
• Handle responses to client feedback on CAPA Reports and deliver updated CAPA Reports as needed
• Attend client calls as needed to present CAPA Reports
• Partner with the client\'s QA Department to ensure client satisfaction
• Track actions promised to clients in CAPA Reports and collect/validate objective evidence of completion
• Perform and oversee Effectiveness Checks to measure success of actions on schedule, as needed

Additional Responsibilities

• Supporting At-Risk Client initiatives including non-standard requests for trend analysis, Post-Mortems, Quality Improvement Plans (QIPs), Remediation Plans
• Routine client-facing CR reporting outside of formal CAPAs (e.g., Excel formats)
• QA-to-QA client partnerships including routine meetings and reporting on Key Quality Indicators (KQIs) and reviewing Quality Assurance Agreements (QAAs)
• Client QBR meeting support

Process Development

• Manage CAPA Issue Form improvements
• Regularly assess workflow to ensure efficiency
• Monitor initiation, tracking, and storage mechanisms
• Note training gaps and partner with L&D to mitigate
• Maintain CAPA-related Bookstack reference content
• Track CAPA data to identify trends
• Decrease the overall volume of CAPA reports by guiding users to resolve issues without a formal report (e.g., informal updates via email, meetings, QBRs)
• Complete other tasks as assigned by management

Required Qualifications & Experience

• Minimum bachelor's degree or equivalent
• Experience in complaint handling and due diligence
• Fluency in English (written and verbal)
• Excellent writing skills and knowledge of appropriate client language
• Excellent organizational skills and the ability to self-monitor 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

• Trend/data analysis experience
• Experience in root cause analysis methodologies

In order to apply, please submit your CV in English.

Seniority level

• Associate

Employment type

• Full-time

Job function

• Quality Assurance and Writing/Editing

Industries

• Translation and Localization

#J-18808-Ljbffr

---