What are the responsibilities and job description for the Quality Engineer position at United Pharma?
Role Overview
Seeking experienced engineers to support deviation investigations in a GMP-regulated sterile manufacturing environment. This role involves leading technical investigations, supporting quality systems, and driving CAPA activities.
Key Responsibilities
• Lead and author deviation investigations using root cause analysis tools(5-Why, Fishbone, 6M)
• Collaborate with SMEs to gather technical data and support investigations
• Manage investigation records in an electronic QMS (Veeva or similar)
• Present findings in Deviation Review Board meetings
• Support CAPA creation, documentation, and tracking
Requirements
• Engineering degree (Chemical, Mechanical, Industrial, Bio, or related)
• 3 years in GMP-regulated manufacturing (pharma, medical device, etc.)
• 1 year experience in deviation investigation writing
• Hands-on experience with QMS tools (Veeva preferred)
• Strong knowledge of GMP, GDP, and 21 CFR Part 210/211
• Excellent technical writing and communication skills