CAPA Expert

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 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 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 savings

• Consistency in reporting for clients

• Shorter report turnaround times (TATs)

• Effectiveness Checks diligence

• A decrease in the overall volume of CAPAs being requested

• The 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.

Description

CAPA Report Management:

• Initial intake to determine if a CAPA Report is in fact warranted and appropriate based on the severity of error and its impact

• Preflight of CAPA requests to survey the client relationship and type of report needed (NTF, NC, CAPA)

• Ensure all relevant CRs are properly documented in TransPerfect's Quality Management System (QMS)

• Create an internal schedule for CR investigation(s), approval(s), drafting, delivery

• Follow up to ensure everything is on track

• Write the CAPA Report based on the CRs

• Host and lead CAPA call(s) with all relevant parties to ensure everyone agrees in the content

• Ensure QA compliance and avoid any audit risks

• Deliver to the client-facing POC

• Maintain internal storage of CAPA Reports and associated documentation

• Handle any responses to client feedback on CAPA Reports and deliver updated CAPA Reports, as needed

• Attend client calls as needed to present CAPA Report

• Partner with client's QA Department to ensure client satisfaction

• Track actions as promised to clients in CAPA Reports and collect/validate objective evidence of completion

• Perform and oversee Effectiveness Checks to measure success of the actions upon scheduled timeframes, as needed

Additional Responsibilities:

• Supporting At-Risk Client initiative 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 format)

• QA-to-QA client partnerships including routine meetings, reporting on Key Quality Indicators (KQIs), reviewing Quality Assurance Agreements (QAAs)

• Client QBR Meeting support

• Routine client audit support

Process Development:

• Manage CAPA Request Form improvements

• Regularly assess workflow to ensure efficiency

• Monitor initiation, tracking, and storage mechanisms

• Take note of 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 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

• Experience in complaint handling and due diligence

• Fluency in English (written and verbal)

• 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:

• Trend/data analysis experience

• Experience in root cause analysis methodologies