Qualified Person (Steriles)
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 (Steriles) / Quality Assurance
Builds
Injectables, tablets, and polymeric delivery forms
Domain
Pharmaceutical manufacturing / Sterile products
Deliverable
client delivery
Required skills
cGxP knowledge, root cause analysis, corrective and preventive actions, change management, validation and qualification oversight, regulatory compliance, lean thinking
Preferred skills
Experience as a Qualified Person, proactive quality mindset
Technologies
GxP systems, validation tools
Responsibilities
Ensure correct handling of complaints, verify compliance with regulations and cGMP, independently authorize batch release and certification, maintain quality policy and procedures, initiate and approve root cause investigations, advise production units on compliance, support health authority inspections
Seniority
Mid-level, hands-on IC
