Hetero Quality Analyst Interview Questions and Answers for Experienced

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

I am seeking new opportunities to grow professionally and expand my skill set.

• Looking for a company that values continuous learning and development

• Seeking a more challenging and dynamic work environment

• Want to work with a team that promotes collaboration and innovation

• Desire to explore new technologies and methodologies

• Seeking better career growth prospects and opportunities for advancement

I have 5 years of experience as a Quality Analyst.

• I have worked in various industries, including software development and manufacturing.

• I am proficient in using quality assurance tools and techniques.

• I have experience in conducting quality audits and inspections.

• I have successfully implemented quality improvement initiatives.

• I have strong analytical and problem-solving skills.

• I have excellent communication and document...read more

Yes, I know integration.

• Integration is the process of combining different components or systems to work together seamlessly.

• It involves testing the interfaces between the components to ensure they communicate effectively.

• Examples of integration include integrating a payment gateway into an e-commerce website or integrating a CRM system with a marketing automation tool.

There are different types of integration such as vertical, horizontal, forward, backward, and bi-directional.

• Vertical integration involves the integration of different levels of the same supply chain.

• Horizontal integration involves the integration of different companies at the same level of the supply chain.

• Forward integration involves the integration of a company with its distributors or retailers.

• Backward integration...read more

pH stands for potential of hydrogen.

• pH is a measure of the acidity or alkalinity of a solution.

• It is a logarithmic scale ranging from 0 to 14.

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

• pH is commonly used in various fields such as chemistry, biology, and environmental science.

The aufbau principle is a rule in quantum mechanics that states how electrons fill atomic orbitals.

• The principle states that electrons fill the lowest energy levels first before moving to higher energy levels.

• It follows the order of filling orbitals: 1s, 2s, 2p, 3s, 3p, 4s, etc.

• Each orbital can hold a maximum of two electrons with opposite spins.

• For example, the electron configuration of carbon (atomic number 6) is 1s²

Electron pairing occurs after half-filled orbitals in a subshell.

• Electron pairing is a phenomenon where two electrons occupy the same orbital.

• This occurs after each orbital in a subshell has been half-filled with electrons.

• The pairing of electrons is due to the principle of maximum multiplicity.

• For example, in the p subshell, electron pairing occurs after the first three orbitals have been half-filled with electrons.

RSD stands for Relative Standard Deviation and is a measure of the variability of a sample compared to its mean.

• RSD is calculated by dividing the standard deviation of a sample by its mean and multiplying by 100.

• It is expressed as a percentage and is often used in analytical chemistry to assess the precision of a method.

• A low RSD indicates that the data is precise and consistent, while a high RSD indicates that the dat...read more

System suitability parameters for HPLC ensure the proper functioning of the system and accuracy of results.

• Retention time of the analyte

• Resolution between peaks

• Theoretical plates

• Peak symmetry factor

• Limit of detection and quantification

• Accuracy and precision of the system

• Mobile phase composition and pH

• Column temperature and pressure

• Flow rate and injection volume

Dissolution is the process by which a solid substance dissolves in a solvent to form a solution.

• The first stage is the wetting stage, where the solid substance comes into contact with the solvent.

• The second stage is the dissolution stage, where the solid substance dissolves in the solvent.

• The third stage is the diffusion stage, where the dissolved substance diffuses away from the solid surface into the bulk of the solv...read more

There are various types of tablets available in the market, including standard tablets, mini tablets, and convertible tablets.

• Standard tablets are the most common type and come in various sizes.

• Mini tablets are smaller in size and are more portable.

• Convertible tablets can be used as both a tablet and a laptop.

• Examples of popular tablets include the iPad, Samsung Galaxy Tab, and Microsoft Surface.

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