Specialist Quality Services (Product Complaints)
Core
Handle Product Technical Complaints (PTC) for medical devices, pharmaceutical products, biologics, and combination products, ensuring compliance with regulatory standards and patient safety.
Role type
Specialist Quality Services (Product Complaints)
Builds
Global quality processes for product complaints
Domain
Life Sciences / Pharmaceutical Quality Management
Required skills
Problem-solving, attention to detail, organizational skills, analytical skills, multitasking
Preferred skills
Knowledge of pharmaceutical quality functions, ability to work in a team-oriented and flexible manner
Technologies
QualiPSO, Global complaint management systems
Responsibilities
Handle PTCs for various product types; manage complaints into databases and perform assessments; categorize complaints based on impact on quality or patient safety; follow up with complainants for additional information; ensure compliance with GxP and regulatory requirements; process toll-out manufacturing complaints; coordinate with cross-functional teams including Pharmacovigilance and Field Alert Reporting.
Seniority
Junior, hands-on IC