Proactive Quality Assurance Specialist

Há 2 dias

São Paulo, São Paulo, Brasil beBeeQuality Tempo inteiro US$90.000 - US$105.000
Job Title:

Corrective and Preventive Action Expert

Job Description

The Global Quality Management System relies heavily on the skills of a corrective and preventive action expert. This role plays a crucial part in ensuring compliance with international and local statutory and regulatory requirements.

Formal client-facing reports related to non-conformances documented in Compliance Reports (CRs) are a key aspect of this position. The expert drives the CAPA process from start to finish, aiming to minimize impact on operations and pass along internal cost savings.

  • Minimize impact on operations and pass along internal cost savings
  • Maintain consistency in reporting for clients
  • Reduce report turnaround times
  • Decrease the overall volume of CAPAs being requested
CAPA Report Management

Key responsibilities include initial intake to determine if a CAPA Report is warranted and appropriate based on severity and impact. The expert preflights CAPA requests to survey the client relationship and type of report needed. All relevant CRs must be properly documented in the QMS.

  • Preflight CAPA requests to survey the client relationship and type of report needed
  • Create an internal schedule for CR investigation, approval, drafting, and delivery
  • Write the CAPA Report based on the CRs
  • Host and lead CAPA calls with relevant parties to ensure alignment on content
  • Deliver the CAPA Report to the client-facing point of contact
  • Maintain internal storage of CAPA Reports and associated documentation
Additional Responsibilities

Supporting At-Risk Client initiatives, routine client-facing CR reporting outside of formal CAPAs, and QA-to-QA client partnerships are also essential duties. The expert manages CAPA Issue Form improvements, regularly assesses workflow to ensure efficiency, and monitors initiation, tracking, and storage mechanisms.

  • Supporting At-Risk Client initiatives
  • Routine client-facing CR reporting outside of formal CAPAs
  • QA-to-QA client partnerships
Process Development

Developing and improving processes is a vital part of this role. The expert should focus on managing CAPA Issue Form improvements, regularly assessing workflow to ensure efficiency, and monitoring initiation, tracking, and storage mechanisms.

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