Writer, Complaint
Core
Implement and maintain Quality System Support for pharmaceutical, medical device, and combination product complaints, ensuring compliance with regulations and company policies.
Role type
Quality System Support Specialist (Complaints)
Builds
Quality compliance and complaint resolution processes for plant events
Domain
Pharmaceutical manufacturing / Quality Assurance
Deliverable
client delivery
Required skills
Quality/Compliance management, regulatory standards knowledge (API, Bulk Drug, Finished Goods), product impact analysis, QA hold procedures, investigation documentation, cross-functional liaison
Preferred skills
Biology, Chemistry, or Engineering background, manufacturing experience
Technologies
None stated
Responsibilities
Implement and maintain Quality System Support effectiveness, complete thorough investigations of plant events, perform product impact analyses and place product on QA hold, maintain liaison with other Quality areas
Seniority
Mid-level, hands-on IC
