Quality Engineer I/II

Job Summary

A company is looking for a Quality Engineer I/II - Solid Dose.

Key Responsibilities

• Collaborate and approve GMP related documents for accuracy and compliance
• Provide QA input to manufacturing documentation to ensure product quality
• Support quality assurance methodologies and participate in regulatory inspections

Required Qualifications

• Bachelor's Degree in a scientific or engineering related field
• 1+ years of relevant pharmaceutical industry experience for Quality Engineer I; 3+ years for Quality Engineer II
• Familiarity with QA and cGMP principles and FDA Quality System regulations
• Strong technical writing skills and proficiency in Microsoft Office applications
• Knowledge of US FDA, EU, and JP GMP regulations