Sri Krishna Pharmaceuticals Quality Manager 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

Normality refers to the state of being normal or conforming to a standard or average.

• Normality is a concept used in various fields to define what is considered typical or expected.

• It is often used in statistics to describe the distribution of data points around a mean.

• In psychology, normality refers to behavior that is within the range of what is considered socially acceptable.

• Normality can also be subjective, varying ...read more

Molarity is a measure of the concentration of a solution expressed as the number of moles of solute per liter of solution.

• Molarity is calculated by dividing the number of moles of solute by the volume of the solution in liters.

• It is denoted by the symbol 'M'.

• Molarity is commonly used in chemistry to express the concentration of a solution.

• For example, a 1 M solution of sodium chloride contains 1 mole of sodium chloride

Molarity is the concentration of a solution in terms of the number of moles of solute per liter of solution, while molality is the concentration of a solution in terms of the number of moles of solute per kilogram of solvent.

• Molarity is denoted by M, while molality is denoted by m.

• Molarity is affected by temperature changes, while molality is not.

• Molarity is used in chemical reactions, while molality is used in colliga...read more

HPLC stands for High Performance Liquid Chromatography. It is a principle used in analytical chemistry to separate, identify, and quantify components in a mixture.

• HPLC uses a liquid mobile phase and a solid stationary phase to separate components based on their interactions with the stationary phase.

• The principle is based on the differential partitioning of components between the mobile and stationary phases.

• Components...read more

The principle of UV-spectrophotometer is based on the absorption of ultraviolet (UV) light by molecules.

• UV-spectrophotometer measures the absorbance of UV light by a sample.

• The absorbance is directly proportional to the concentration of the absorbing species in the sample.

• The principle is used in various applications such as quantitative analysis, purity determination, and kinetics studies.

• UV-spectrophotometer operates...read more

Quality assurance focuses on preventing defects while quality control focuses on identifying and correcting defects.

• Quality assurance is a proactive process that involves planning, designing, and implementing processes to prevent defects from occurring.

• Quality control is a reactive process that involves identifying defects and taking corrective action to eliminate them.

• Quality assurance is focused on the entire process...read more

I worked as a Quality Analyst at XYZ Company for 2 years.

• Conducted quality assurance testing on software applications

• Identified and reported bugs and issues to development team

• Collaborated with stakeholders to ensure product met quality standards

There are three types of validations: front-end, back-end, and database. Each type requires a different approach.

• Front-end validation is done on the client-side and checks for user input errors before submitting the form.

• Back-end validation is done on the server-side and checks for errors in the data submitted by the user.

• Database validation checks for data integrity and consistency in the database.

• Handling of validati...read more

Calibration of instruments is a crucial process to ensure accuracy and reliability of measurements.

• Calibration involves comparing the measurements of an instrument to a known standard.

• It helps in identifying and correcting any deviations or errors in the instrument's readings.

• Calibration ensures that the instrument is performing within acceptable limits and provides accurate results.

• It is necessary to calibrate instrum...read more

HPLC is a technique used to separate, identify, and quantify components in a mixture based on their interaction with a stationary phase and mobile phase.

• HPLC stands for High-Performance Liquid Chromatography.

• The principle of HPLC involves the separation of components in a mixture based on their affinity for the stationary phase and mobile phase.

• The instrumentation of HPLC includes a pump to deliver the mobile phase, a ...read more

GC stands for Gas Chromatography, a principle and instrumentation used for separating and analyzing volatile compounds.

• GC is a technique used in analytical chemistry to separate and identify components of a mixture.

• It involves injecting a sample into a gas chromatograph, which vaporizes the sample and carries it through a column.

• The column contains a stationary phase that interacts with the sample components, causing t...read more

UV spectroscopy is a technique that uses ultraviolet light to analyze the chemical composition of substances.

• UV spectroscopy is based on the principle that molecules absorb ultraviolet light at specific wavelengths.

• The Beer-Lambert law relates the concentration of a substance to the amount of light it absorbs.

• UV spectroscopy is commonly used in pharmaceutical, environmental, and forensic analysis.

• It is used to determin...read more