Pharma Quality Compliance Specialist

vor 1 Monat

Schaffhausen, Schaffhausen, Schweiz Randstad - Medium prio Vollzeit
Job Overview

Caring for the world, one person at a time, inspires and unites the people of Johnson & Johnson, we embrace research and science- bringing innovative ideas, products and services to advance the health and well-being of people.

This role is part of a team that ensures continued manufacturing process improvement and addresses potential patient risks by leading Product Quality Investigations based on the feedback received from patients.

The Quality Assurance Specialist performs quality activities in support of new and existing products, ensuring compliance with applicable regulatory requirements and maintaining high-quality marketed products and compliance with all standards.

Main Responsibilities:

  • Review and analyze customer complaints, inspect product returns, investigate technical details, and assist/lead CAPA investigations.
  • Ensure accurate documentation and closure of each complaint to make sound regulatory reporting decisions.
  • Develop a detailed understanding of products and previously investigated complaints in scope.
  • Evaluate market impact of a complaint and escalate critical issues.
  • Review and analyze customer complaint information for trending/risk analysis and corrective action.
  • Support internal, external, and third-party audits.
  • Support project team activities and participate in process improvement projects.

Requirements

  • A Master's Degree or equivalent experience in engineering, physical, biological, or natural sciences.
  • Strong written and verbal communication skills in English.
  • A minimum of 1 year of experience in quality in a pharma/medical device or other regulated industry.
  • Investigative and analytical critical thinking skills.
  • Experience in CAPA root cause investigation execution and implementation of corrective and preventive actions for quality processes.
  • Strong decision-making skills.
  • Continuous interaction with global groups and the ability to collaborate with global customers.

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