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‘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, 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.

Customer Feedback collected by other groups is a valuable indicator for potential Product quality issues. The focus of the QA Pharma Complaint Specialist is the investigation of such potential quality concerns in collaboration with internal manufacturing, QC or devise design experts.

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 Pharma 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.

QA Pharma Complaint Specialist

Specific Responsibilities:

• Investigate product quality concerns based on customer complaints.
• Assessment, coordination and/or investigate assigned customer complaints
• Inspection of returned products, investigation of technical details, and 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.
• Develop a detailed understanding of the products and previously investigated complaints.
• Evaluate of market impact of new complaints and escalate critical issues for immediate action.
• Review and analyse complaint information for trending/risk analysis and corrective actions and resultant effectiveness of these actions.
• Support internal, external, and third-party audits.
• Support additional project team activities and/or investigations, and participate in process improvement projects

Required skills and experience

• A Masters’s Degree, PhD or equivalent experience in engineering, physical, biological, natural sciences is required.
• Strong written and verbal communication skills in English
• Investigative & analytical critical thinking skills.
• Strong decision-making skills – able to make sound business decisions with sometimes limited information.
• 1 year of experience in quality in a pharma/medical device or other regulated industry is preferred but not required
• Knowledge of statistical applications and auditing practices is preferred but not required

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