Simplex Infrastructures Interview Questions and Answers

Batch size selection for commercial products depends on various factors.

• Batch size should be based on market demand and production capacity.

• Cost of production and inventory management should also be considered.

• Regulatory requirements and shelf life of the product are important factors.

• Batch size can vary depending on the complexity of the manufacturing process.

• Examples: Pharmaceutical companies may produce smaller batches for clinical trials and larger batches for commercial ...read more

Qualified ranges of equipment sizes.

• Equipment sizes vary depending on the industry and application.

• Qualified ranges ensure proper functioning and safety.

• Examples include medical equipment, construction machinery, and electronics.

• Ranges may be determined by regulations, manufacturer specifications, or industry standards.

Instrument calibration is the process of verifying and adjusting the accuracy of measuring instruments to ensure reliable results.

• Calibration involves comparing the readings of an instrument to known standards.

• Procedures typically include adjustments to bring the instrument into alignment with the standard.

• Regular calibration ensures accuracy and reliability of measurements.

• Examples of instruments that require calibration include thermometers, pressure gauges, and scales.

Occupancy of equipment refers to the percentage of time that equipment is being used.

• Occupancy can be calculated by dividing the total time the equipment is being used by the total time it is available.

• High occupancy rates indicate efficient use of equipment and can lead to increased productivity.

• Low occupancy rates may indicate that equipment is not being utilized effectively or that there is excess capacity.

• Examples of equipment that can be measured for occupancy include ma...read more

OOS investigation refers to the process of investigating out-of-specification results in a manufacturing or testing environment.

• Identify the root cause of the OOS result

• Review all relevant documentation and procedures

• Implement corrective and preventive actions

• Document the investigation process and findings

Regulatory affairs professionals ensure compliance with laws and regulations in various industries.

• Develop and implement regulatory strategies

• Ensure products meet safety and quality standards

• Interact with regulatory agencies for approvals and compliance

• Stay updated on changing regulations and guidelines

• Provide guidance on labeling and advertising requirements

MLT stands for Machine Learning Technician. It involves performing various tasks related to machine learning.

• MLT involves collecting and cleaning data for training machine learning models.

• MLT requires selecting and implementing appropriate machine learning algorithms.

• MLT involves training and evaluating machine learning models using the collected data.

• MLT also includes optimizing and fine-tuning machine learning models for better performance.

• MLT requires staying updated with ...read more

Troubleshooting of instrument involves identifying and resolving issues with the functionality of the instrument.

• Identify the specific issue or symptom affecting the instrument

• Check for any error messages or indicators on the instrument

• Inspect the physical components for any damage or malfunctions

• Consult the instrument manual or manufacturer's guidelines for troubleshooting steps

• Consider seeking assistance from technical support or a professional technician if needed