Specialist - QA Pharma Complaints

Johnson & Johnson seeks a Mid-level Specialist for QA Pharma Complaints in Schaffhausen. The role focuses on investigating product quality issues, conducting root cause analyses, and ensuring regulatory compliance through cross-functional collaboration.

This position is responsible for leading product quality investigations driven by feedback from patients and customers. By identifying quality risks and improvement opportunities, the specialist helps safeguard product integrity. The role offers a comprehensive view of the pharmaceutical product lifecycle through daily interaction with various internal teams.

Responsibilities

• Examine product quality issues raised through customer complaints.
• Manage, coordinate, and conduct investigations into assigned complaints.
• Inspect returned items, analyze technical details, perform root cause and risk assessments, and lead Corrective and Preventive Action (CAPA) investigations.
• Maintain precise documentation and ensure timely closure of complaints to support regulatory reporting.
• Build a thorough understanding of products and historical complaint data.
• Assess the market impact of new complaints and escalate critical issues for immediate action.
• Analyze complaint data for trends, risks, and the effectiveness of corrective actions.
• Assist in internal, external, and third-party audits.
• Participate in additional project activities, investigations, and process improvement initiatives.

Requirements

• A Master’s degree, PhD, or equivalent experience in engineering, physical, biological, or natural sciences.
• Strong written and verbal communication skills in English.
• Investigative and analytical critical thinking abilities.
• Strong decision-making skills, with the ability to make sound business decisions even with limited information.

Nice to have

• One year of experience in quality within the pharma, medical device, or other regulated industries is preferred.
• Knowledge of statistical applications and auditing practices is preferred.

What the company offers

• The company supports successful candidates through country-specific checks prior to employment start.

About the company

Johnson & Johnson operates under its Credo, demonstrating responsibility to its global workforce. The organization fosters an inclusive environment that values each individual, respecting diversity and dignity while recognizing merit. The hiring process aims to be clear, fair, and respectful of candidate time.

• Guided by the Johnson & Johnson Credo.
• Inclusive work environment valuing individuals.
• Respect for diversity and employee dignity.
• Fair and respectful hiring process.

How to apply

Documents to submit:

• CV