Expert Quality Services (Product Complaints)
Core
Manage Product Technical Complaints (PTC) for medical devices, pharmaceuticals, biologics, and combination products to ensure regulatory compliance and patient safety.
Role type
Senior Quality Operations Specialist (Complaint Management)
Builds
Global Quality Management System (QMS) records and complaint databases
Domain
Life Sciences / Pharmaceutical Quality Assurance
Required skills
cGMP knowledge, complaint database software proficiency, regulatory standards compliance, data privacy management, sample management, adverse event identification, fast-track complaint processing, stakeholder collaboration, documentation review, quality checkpoint execution
Preferred skills
Manufacturing site experience, problem-solving in stressful environments, multitasking, continuous improvement initiatives
Technologies
Global complaint management systems, reporting tools, QMS software
Responsibilities
Handle and categorize Product Technical Complaints (PTC) based on impact on product quality or patient safety; Conduct assessment and timely processing of complaints into proper databases; Ensure compliance of documentation and Quality processes with applicable regulations; Manage sample collection, tracking, and closure of complaints; Communicate with internal/external stakeholders (Manufacturing, PV, Regulatory, Legal) for complaint resolution; Support audits and regulatory inspections; Create and review Standard Operating Procedures (SOPs) and training materials.
Seniority
Senior, hands-on IC
