Sample interview questions: Have you conducted equipment qualification and validation activities for new manufacturing installations in compliance with regulations? If yes, describe your approach.
Sample answer:
- Conducted equipment qualification (EQ) and validation (EV) activities in accordance with current Good Manufacturing Practices (cGMP) and regulatory requirements.
- Developed comprehensive EQ and EV protocols and documentation, ensuring compliance with regulatory bodies such as the FDA, EMA, and ICH.
- Implemented robust EQ and EV procedures, including installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ), to ensure equipment meets design specifications and performs as intended.
- Collaborated with cross-functional teams, including quality assurance, production, engineering, and maintenance, to ensure successful EQ and E… Read full answer
Source: https://hireabo.com/job/3_4_4/Manufacturing%20Engineer