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CAPA Project Lead

CAPA Project Lead

QRC Group, LLCGurabo, PR, pr
Hace 29 días
Tipo de contrato
  • Quick Apply
Descripción del trabajo

Job Description

The CAPA Project Lead plays a critical role in ensuring the timely and compliant execution of Corrective and Preventive Actions (CAPAs) across the organization. The role includes oversight of the Management Review process, identifying delays in investigations, and collaborating cross-functionally to ensure closure within defined timelines and regulatory expectations.

Responsibilities :

  • Monitor and track CAPA progress across departments to ensure timely execution and regulatory compliance.
  • Review investigation timelines and escalate delays to appropriate stakeholders.
  • Support the Management Review process by preparing metrics, identifying trends, and highlighting overdue actions.
  • Collaborate with investigation owners to ensure CAPA documentation meets internal and external quality standards.
  • Identify systemic issues or bottlenecks in the CAPA process and propose process improvements.

Requirements

  • Bachelor’s degree in Life Sciences, Engineering, or related field.
  • Minimum 10 years of experience in the pharmaceutical or biotech industry, preferably in Quality Assurance or Quality Systems.
  • Strong understanding of GMP, FDA, and ICH guidelines related to CAPA and investigations.
  • Excellent organizational and time management skills.
  • Proactive mindset with strong analytical and problem-solving abilities.
  • Effective written and oral communication skills.
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    Capa Project Lead • Gurabo, PR, pr

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