K.s. Securesolutions Interview Questions and Answers

Autoclave tests ensure proper functioning and sterilization of equipment.

• Biological indicator testing to ensure proper sterilization

• Physical testing to ensure proper temperature and pressure

• Chemical testing to ensure proper chemical indicators are met

• Leak testing to ensure proper seal and prevent contamination

• Cycle testing to ensure consistent performance over time

I have a strong knowledge of injectable pharmaceuticals and GMP guidelines.

• I am familiar with the manufacturing process of injectable pharmaceuticals, including sterile compounding and packaging.

• I understand the importance of following GMP guidelines to ensure the quality and safety of pharmaceutical products.

• I am aware of the regulations and standards set by regulatory bodies such as the FDA and EMA for manufacturing injectable pharmaceuticals.

• I have experience in implementi...read more

Tests performed for HVAC include airflow measurement, temperature measurement, pressure measurement, and refrigerant leak detection.

• Airflow measurement: Testing the volume of air being circulated by the HVAC system using an anemometer.

• Temperature measurement: Checking the temperature of the air at various points in the system using thermometers or temperature sensors.

• Pressure measurement: Assessing the pressure levels within the HVAC system using pressure gauges.

• Refrigerant l...read more

Tests performed for tunnel

• Permeability test

• Water pressure test

• Load test

• Visual inspection

• Geotechnical investigation

CAPA stands for Corrective and Preventive Action, while OOS stands for Out of Specification.

• CAPA is a process used to identify, investigate, and resolve quality issues.

• OOS refers to a result that falls outside of predetermined specifications.

• CAPA and OOS are both important in maintaining quality control in various industries.

• In the medical field, CAPA and OOS are crucial for ensuring patient safety and regulatory compliance.

The number of test parameters in an API product can vary depending on the complexity and functionality of the product.

• The number of test parameters in an API product is determined by the different inputs, outputs, and functionalities that need to be tested.

• Common test parameters in API products include authentication, request parameters, response codes, error handling, and performance metrics.

• The number of test parameters can range from a few dozen to hundreds, depending on t...read more

Regulatory guidelines are essential for ensuring compliance with QMS standards.

• ISO 9001:2015 is the most widely recognized QMS standard

• FDA regulations apply to medical device manufacturers

• EU MDR 2017/745 is the new regulation for medical devices in the European Union

• Regulatory guidelines provide a framework for implementing and maintaining QMS

• Non-compliance with regulatory guidelines can result in fines, legal action, and damage to reputation

Change controls are procedures used to manage changes to a system or process.

• Documenting the change request

• Assessing the impact of the change

• Obtaining approval for the change

• Implementing the change

• Testing the change

• Reviewing and closing the change request