QA Pharma Complaint Specialist (w/m/d).

'Caring for the world, one person at a time'… inspires and unite 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.

High quality is build into all manufacturing and quality processes in Schaffhausen, yet still products are sometimes reported by our patients in a state that is not in line with our expectations. To ensure continued manufacturing process improvement and to address potential patients risks Product Quality Investigations are lead by QA Pharma Complaints Specialists based on the feedback received from our patients.

The QA Complaint Specialist performs quality activities in support of new and existing products. The position has a great deal of interaction with many internal departments, including Engineering, Manufacturing, Purchase, Quality Control, and global Partners. The QA Complaint Specialist performs a wide variety of activities to ensure compliance with applicable regulatory requirements, and ensures the high quality of the marketed products and compliance with all standards; documentation reviews; support quality audits; and sophisticated data analysis.

Due to the diversity of contact points with Quality, Laboratory, Manufacturing, Engineering and Regulatory functions this role is especially well suited to build a solid understanding of the End-to End development and lifecycle of pharma-products.

Main Responsibilities:

• Review, analyze, coordinate and/or investigate of assigned customer complaints
• Inspection of product returns, investigation of technical details, root cause analysis, risk assessment, and assist/lead associated CAPA investigations
• Ensure accurate documentation and closure of each complaint in order to make and document sound regulatory reporting decisions/justifications
• Develop a detailed understanding of the products and previously investigated complaints in scope
• Evaluate market impact of a complaint and escalate critical issues for immediate action
• Review and analysis of customer complaint information for trending/risk analysis and corrective action and resultant effectiveness of action
• Support internal, external, and third-party audits
• Support additional project team activities and/or investigations, and participate in process improvement projects