Qualified Person (Solids)
Core
Responsible for the quality and release of assigned batches of bulk product, packaged product, raw materials, and medical devices in a pharmaceutical manufacturing setting.
Role type
Qualified Person (QP) for Solids
Builds
Pharmaceutical products including injectables, tablets, and polymeric delivery forms
Domain
Pharmaceutical manufacturing / Quality Assurance
Deliverable
client delivery
Required skills
cGxP knowledge, root cause analysis, corrective and preventive actions, regulatory compliance, lean thinking, batch release and certification, deviation management, investigation leadership
Preferred skills
Experience as a Qualified Person, change management, equipment qualification and validation support
Technologies
GxP systems, manufacturing execution systems
Responsibilities
Ensure correct handling of complaints, maintain up-to-date quality policy and procedures, advise production units on compliance, approve deviations and investigations, initiate and approve root cause analyses, support health authority inspections, collaborate with QA officers, specialists, and production teams
Seniority
Mid-level, hands-on IC
