Bajaj Healthcare Quality Analyst Interview Questions and Answers

Data integrity refers to the accuracy, consistency, and reliability of data throughout its lifecycle.

• Data integrity ensures that data remains unchanged and reliable over time.

• It involves maintaining the accuracy and consistency of data during storage, processing, and transmission.

• Data integrity can be achieved through various measures such as checksums, encryption, and access controls.

• Examples of data integrity issues ...read more

CAPA stands for Corrective and Preventive Action.

• CAPA is a systematic approach to identify, investigate, and resolve quality issues.

• It involves analyzing the root cause of the problem and implementing corrective actions to prevent recurrence.

• CAPA is commonly used in industries such as manufacturing, pharmaceuticals, and healthcare.

• Examples of CAPA tools and techniques include 5 Whys, Fishbone Diagrams, and Pareto Analy

Calibration is required to ensure accuracy and consistency of measurements and equipment.

• Calibration helps to maintain the quality of products and services.

• It ensures that measurements are accurate and consistent, reducing errors and improving efficiency.

• Calibration is necessary for compliance with industry standards and regulations.

• Examples of equipment that require calibration include scales, thermometers, and medica...read more

I would clarify the reason behind the request and discuss any potential impact on the analysis.

• Ask for clarification on the reason for skipping the step

• Discuss any potential impact on the analysis

• Provide alternative solutions if possible

PH stands for potential of hydrogen. It is a measure of the acidity or alkalinity of a solution.

• PH is a scale ranging from 0 to 14.

• A pH of 7 is considered neutral, below 7 is acidic, and above 7 is alkaline.

• The pH of common substances: lemon juice (2), water (7), baking soda (9).

Negative logarithm of base 10 is used to find the number of times 10 must be multiplied to get the given number.

• Negative logarithm of base 10 is denoted as -log10(x)

• It is used to find the pH value of a solution in chemistry

• It is also used to measure the intensity of earthquakes using the Richter scale

Troubleshooting of HPLC system involves identifying and resolving issues to ensure accurate and reliable results.

• Check for leaks in the system

• Inspect and clean the column

• Verify the mobile phase composition

• Calibrate and check the detectors

• Troubleshoot software or connectivity issues

• Perform system suitability tests

• Consult instrument manuals or contact technical support if needed

Dissolution test is performed to determine the rate at which a drug substance dissolves in a specified medium.

• Prepare the dissolution medium according to the specified requirements.

• Calibrate the dissolution apparatus by measuring the rotation speed, temperature, and other parameters.

• Place the drug substance in the dissolution vessel and start the test.

• Collect samples at specified time intervals and analyze the amount o...read more

Data integrity is crucial for ensuring accuracy and reliability of data. ALCOA and ALCOA Plus are guidelines for data integrity.

• ALCOA stands for Attributable, Legible, Contemporaneous, Original, and Accurate

• ALCOA Plus adds the principles of Complete, Consistent, Enduring, and Available

• These guidelines ensure that data is recorded accurately, completely, and consistently throughout its lifecycle

• Examples of ALCOA and ALC...read more

UV operation and calibration involves setting up and maintaining the equipment to ensure accurate readings.

• UV equipment must be properly installed and calibrated before use

• Regular maintenance and cleaning is necessary to ensure accurate readings

• Calibration should be performed using a certified reference material

• UV equipment should be regularly checked for accuracy using a calibration curve

• Proper training and documentat