Specialist Quality Complaints

We are seeking a Specialist Quality Complaints professional to join our Product Complaints and Surveillance team. In this critical role, you will be responsible for conducting complex complaint investigations, ensuring the quality of complaint records, and resolving corrective actions. The ideal candidate will have a background in the biotech or pharmaceutical industry, with the ability to apply strong analytical skills to evaluate complex situations and prevent potential regulatory issues. You will be a key player in ensuring our global complaint processes and systems are compliant with internal and external requirements, ultimately driving continuous improvement.

Responsibilities

• Complaint Investigation : Conduct complex complaint investigations and ensure the quality of all complaint records.
• Corrective Actions : Resolve corrective actions and verify their effectiveness to ensure the proper level of control for products in distribution.
• Regulatory Compliance : Execute regulatory and Standard Operating Procedure (SOP) requirements. Anticipate and prevent potential issues with regulators and raise potential quality issues to management.
• Evaluation & Guidance : Apply strong analytical abilities to evaluate complex situations using multiple sources of information. Provide guidance and technical advice, and evaluate assessments from subject matter experts.
• Continuous Improvement : Contribute to the end-to-end global complaint process and management system, translating information from the market to drive continuous improvement.

Qualifications

Competencies

Skills Required

complaint investigations , Service Improvement, Project Management, Testing Process, Manufacturing Planning, Analytical Skills