100+ QC Executive Interview Questions and Answers

Various instruments are used in QC such as spectrophotometers, chromatographs, pH meters, balances, and microscopes.

• Spectrophotometers are used to measure the amount of light absorbed by a sample.

• Chromatographs are used to separate and analyze components in a mixture.

• pH meters are used to measure the acidity or alkalinity of a solution.

• Balances are used to measure the mass of a sample.

• Microscopes are used to observe and analyze small samples.

KF is used to measure water content in a sample while LOD is used to measure the amount of volatile matter in a sample.

• KF stands for Karl Fischer titration and is used to measure the water content in a sample.

• LOD stands for Loss on Drying and is used to measure the amount of volatile matter in a sample.

• KF is more accurate than LOD for measuring water content.

• LOD is more commonly used in the pharmaceutical industry to determine the amount of moisture in a drug substance.

• Both K...read more

Proper storage and handling of fruits and vegetables is crucial to maintain their freshness and quality.

• Fruits and vegetables should be stored in a cool and dry place to prevent spoilage.

• They should be stored separately to avoid cross-contamination.

• Certain fruits and vegetables, like apples and potatoes, emit ethylene gas which can accelerate ripening of other produce. They should be stored separately.

• Leafy greens should be stored in airtight containers or plastic bags to ret...read more

A buffer solution is a solution that resists changes in pH when small amounts of acid or base are added. POH is the negative logarithm of the hydroxide ion concentration.

• Buffer solution helps maintain a stable pH by neutralizing added acids or bases

• Buffer solutions are made by mixing a weak acid and its conjugate base, or a weak base and its conjugate acid

• POH is the negative logarithm of the hydroxide ion concentration in a solution

• POH can be calculated using the formula POH ...read more

Caffeine is used for calibration of HPLC due to its well-defined retention time and peak shape.

• Caffeine has a well-defined retention time, making it easy to identify and calibrate the HPLC system.

• Caffeine produces a sharp and symmetrical peak, which helps in accurately determining the system's performance.

• It is a commonly used compound for calibration in HPLC due to its stability and reproducibility.

• Using caffeine as a calibration standard allows for consistent and reliable r...read more

Operating principles of instruments involve understanding how they work and troubleshooting involves identifying and fixing issues.

• Understand the basic principles of how the instrument functions

• Follow manufacturer's instructions for operating the instrument

• Regularly calibrate and maintain the instrument to ensure accuracy

• Troubleshooting involves identifying common issues such as calibration errors or sensor malfunctions

• Use diagnostic tools or consult technical support for mor...read more

TLC (Thin Layer Chromatography) is a technique used to separate and analyze mixtures. Ion chromatography is a method for separating and analyzing ions in a solution.

• TLC involves a stationary phase on a flat plate, where compounds move at different rates based on their affinity for the stationary phase.

• Ion chromatography separates ions based on their charge and affinity for the stationary phase.

• TLC is commonly used in drug analysis and forensics to identify compounds in mixtur...read more

Fat is a type of lipid composed of fatty acids and glycerol. It is an essential nutrient and a concentrated source of energy.

• Fat is a macronutrient that is insoluble in water.

• It is made up of triglycerides, which consist of three fatty acid molecules attached to a glycerol molecule.

• Fat serves as a vital energy reserve in the body.

• It provides insulation and protection to organs.

• Fat is involved in the absorption of fat-soluble vitamins.

• Examples of dietary fats include butter, o...read more

Calibration of Karl Fischer is a process to ensure accuracy and reliability of the moisture determination method.

• Calibration involves verifying the performance of the Karl Fischer titration system.

• It includes checking the accuracy of the reagents, electrodes, and the instrument itself.

• Calibration is typically done using standard solutions with known moisture content.

• The instrument readings are compared to the expected values to determine any deviations.

• Adjustments are made to...read more

21 CFR guidelines outline stability testing requirements for pharmaceutical products.

• Stability testing is required to ensure the quality and efficacy of pharmaceutical products.

• Testing should be conducted under various conditions, including temperature, humidity, and light exposure.

• Data collected from stability testing is used to determine product expiration dates and storage recommendations.

• Stability testing should be conducted throughout the product's lifecycle, from develo...read more

SDS-PAGE is a technique used to separate proteins based on their size and charge. ELISA is a method to detect and quantify specific proteins or antibodies in a sample.

• SDS-PAGE stands for Sodium Dodecyl Sulfate Polyacrylamide Gel Electrophoresis

• It is commonly used in biochemistry and molecular biology to analyze protein samples

• SDS-PAGE separates proteins based on their molecular weight

• ELISA stands for Enzyme-Linked Immunosorbent Assay

• It is a widely used technique in immunology...read more

Quality control engineers are responsible for ensuring products meet quality standards through testing and inspection.

• Developing and implementing quality control systems and procedures

• Conducting tests and inspections to identify defects or deviations from quality standards

• Analyzing data to determine root causes of quality issues

• Collaborating with production teams to address quality concerns

• Ensuring compliance with regulatory requirements and industry standards

• Continuous impro...read more

R. S in HPLC stands for Relative Standard Deviation.

• R. S is a measure of the precision or reproducibility of an HPLC method.

• It is calculated by dividing the standard deviation of peak areas by the average peak area and multiplying by 100.

• R. S is expressed as a percentage and indicates the variability of peak areas in replicate injections.

• A lower R. S value indicates higher precision and better method performance.

• For example, if the R. S value is 2%, it means that the peak are...read more

The 7 QC tools are used in quality control to identify and solve problems. They include check sheets, histograms, scatter diagrams, control charts, Pareto charts, cause-and-effect diagrams, and flowcharts.

• Check sheets: Used to collect and organize data for analysis.

• Histograms: Used to visualize the distribution of data.

• Scatter diagrams: Used to identify relationships between two variables.

• Control charts: Used to monitor process performance over time.

• Pareto charts: Used to pri...read more

Integration parameters are the settings and configurations used to connect different systems or components together.

• Integration parameters define how data is exchanged between systems

• They include things like API endpoints, authentication methods, data formats, etc.

• Examples include setting up OAuth tokens for API integration, configuring webhooks for real-time data updates

Expected CTC, last CTC, and experience are important factors in determining fit for the role.

• Expected CTC: I am looking for a competitive salary based on my experience and skills.

• Last CTC: My last CTC was $X at my previous company.

• Experience: I have X years of experience in quality control roles.

pH stands for potential of hydrogen and is a measure of acidity or alkalinity of a solution. It is a unitless scale ranging from 0 to 14.

• pH measures the concentration of hydrogen ions in a solution, determining its acidity or alkalinity.

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

• Examples of pH levels: lemon juice (pH 2), water (pH 7), baking soda (pH 9).

Select beverages include coffee, tea, soda, juice, water, beer, and wine.

• Coffee

• Tea

• Soda

• Juice

• Water

• Beer

• Wine

Beverage items are drinks that are consumed for refreshment or enjoyment.

• Beverage items can include soft drinks, juices, coffee, tea, alcoholic drinks, and water.

• They can be hot or cold, carbonated or non-carbonated.

• Beverage items are often served in restaurants, cafes, bars, and at home.

• Quality control for beverage items involves ensuring taste, appearance, and safety standards are met.

Yes, I have experience in writing SOP's.

• I have written SOP's for my previous company.

• I am familiar with the format and structure of SOP's.

• I understand the importance of clear and concise instructions.

• I am able to collaborate with team members to ensure accuracy and completeness.

I always maintain a record of my work and behavior to ensure accountability and improvement.

• I keep a log of my daily tasks and accomplishments

• I regularly seek feedback from my supervisor and colleagues

• I take responsibility for my mistakes and work to correct them

• I strive to maintain a positive and professional attitude at all times

PPAP typically consists of 18 documents.

• PPAP (Production Part Approval Process) typically consists of 18 documents.

• These documents include items such as design records, engineering change documents, and control plans.

• Other documents include material certifications, dimensional results, and inspection records.

• The number of documents may vary depending on the customer's requirements and the complexity of the product.

• PPAP is a standardized process used in the automotive industry...read more

KF stands for Karl Fischer titration, a method for measuring water content in a sample.

• Prepare the KF reagent by mixing iodine, sulfur dioxide, and a base such as pyridine.

• Add the sample to the KF reagent and titrate with a solution of iodine until the endpoint is reached.

• Calculate the water content based on the amount of iodine used in the titration.

• KF is commonly used in the pharmaceutical industry to measure water content in drug substances and products.

My strong point is attention to detail and ability to identify and solve problems.

• Attention to detail

• Problem-solving skills

• Ability to identify issues

• Strong analytical skills

UV visible spectroscopy is a technique used to measure the absorption of ultraviolet and visible light by a substance.

• UV visible spectroscopy involves passing UV and visible light through a sample and measuring the amount of light absorbed at different wavelengths.

• It is commonly used in analytical chemistry to determine the concentration of a substance in a sample.

• UV visible spectroscopy can also be used to study the electronic structure of molecules.

• The absorption spectrum o...read more

To make 0.1M HCL, dilute concentrated hydrochloric acid with water.

• Dilute 1 part of concentrated HCL with 9 parts of water to make 0.1M HCL solution.

• Always add acid to water slowly to prevent splashing and heat generation.

• Use proper protective equipment such as gloves and goggles when handling acids.

HPLC and GC are both analytical techniques used to separate and analyze compounds, but they differ in their principles and applications.

• HPLC stands for High Performance Liquid Chromatography, while GC stands for Gas Chromatography.

• HPLC is used for separating and analyzing compounds that are soluble in liquid, while GC is used for separating and analyzing compounds that are volatile and can be vaporized.

• HPLC uses a liquid mobile phase and a solid stationary phase, while GC use...read more

Yes, I am currently handling Out of Trend (OOT) investigations in my role as QC Executive.

• Yes, I have experience in identifying OOT results and conducting thorough investigations to determine the root cause.

• I have worked on implementing corrective and preventive actions to prevent future OOT occurrences.

• I have also collaborated with cross-functional teams to address OOT issues and ensure compliance with regulatory requirements.

Calibration of HPLC involves verifying the accuracy and precision of the instrument by comparing the results obtained with known standards.

• Calibration of HPLC is essential to ensure accurate and reliable results.

• It involves preparing a series of standard solutions with known concentrations of analytes.

• These standard solutions are then injected into the HPLC system and the peak areas or heights are measured.

• The obtained data is used to create a calibration curve, which relates...read more

Method validation is the process of demonstrating that an analytical method is suitable for its intended purpose.

• Method validation ensures that the method is accurate, precise, specific, and reliable.

• It involves testing the method's performance characteristics such as linearity, accuracy, precision, and robustness.

• Validation also includes determining the method's detection and quantitation limits.

• Examples of validation parameters include recovery, repeatability, and intermedi...read more

There are many types of polymers, including natural and synthetic polymers.

• Polymers are large molecules made up of repeating units called monomers.

• Natural polymers include proteins, DNA, and cellulose.

• Synthetic polymers include plastics, rubber, and nylon.

• Polymers have a wide range of applications in industries such as packaging, textiles, and electronics.

Elemental impurities are trace amounts of heavy metals or other elements that can be present in pharmaceutical products.

• Elemental impurities can come from various sources such as raw materials, equipment, or packaging materials.

• Common elemental impurities include lead, cadmium, mercury, and arsenic.

• Regulatory agencies like the FDA have set limits on elemental impurities in pharmaceutical products to ensure safety.

• Analytical techniques such as ICP-MS are used to detect and qua...read more

When losing weight or becoming thinner.

• I would focus on maintaining a balanced diet and regular exercise routine.

• Consulting with a nutritionist or personal trainer can be helpful in achieving weight loss goals.

• Monitoring progress through measurements and body composition analysis is important.

• Ensuring proper hydration and adequate rest is essential for overall health and weight management.

Some common sampling methods in pharmaceutical quality control include random sampling, stratified sampling, and systematic sampling.

• Random sampling: selecting samples randomly from the entire population

• Stratified sampling: dividing the population into subgroups and then randomly selecting samples from each subgroup

• Systematic sampling: selecting samples at regular intervals from a list or population

• Example: Randomly selecting vials from a batch for testing

FMEA stands for Failure Mode and Effects Analysis. It is a systematic approach to identify and prevent potential failures in a process or product.

• FMEA is a proactive risk assessment tool used in various industries.

• It involves identifying potential failure modes, their causes, and their effects on the process or product.

• The severity, occurrence, and detection of each failure mode are rated to prioritize actions.

• Actions can include design changes, process improvements, or addit...read more

Upstream production involves the creation of the biological material, while downstream production involves the purification and processing of that material.

• Upstream production includes cell culture, fermentation, and other methods to create the biological material.

• Downstream production involves purification, filtration, and other methods to isolate and process the desired product.

• Both upstream and downstream production are critical for the creation of biopharmaceuticals and o...read more

The International Conference on Harmonisation (ICH) is a global initiative to standardize regulations for pharmaceuticals.

• ICH was formed in 1990 by regulatory authorities and pharmaceutical industry representatives from the US, Europe, and Japan.

• Its goal is to ensure the safety, quality, and efficacy of pharmaceutical products by harmonizing guidelines and requirements.

• ICH guidelines cover topics such as clinical trials, pharmacovigilance, quality control, and regulatory subm...read more

UV, FTIR, and KF are analytical instruments used in quality control. Calibration is essential for accurate results.

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

• FTIR spectrophotometer measures the absorption or transmission of infrared radiation by a sample.

• KF titrator is used for the determination of water content in a sample.

• Calibration involves setting up the instrument to ensure accurate and precise measurements.

• Regular maintenance and ...read more

HPLC stands for High Performance Liquid Chromatography, a technique used to separate, identify, and quantify components in a mixture.

• HPLC involves passing a liquid sample through a column filled with a stationary phase, where different components in the sample interact differently with the stationary phase and elute at different times.

• The eluted components are detected and quantified based on their retention times and peak areas.

• HPLC is commonly used in pharmaceutical, enviro...read more

Chemical name and formula are identifiers for specific chemical compounds.

• Chemical name is the common name given to a chemical compound.

• Chemical formula represents the elements and their ratios in a compound.

• Example: Water - Chemical name, H2O - Chemical formula.

Molecular weight is the sum of the atomic weights of all atoms in a molecule.

• Molecular weight is calculated by adding up the atomic weights of all the atoms in a molecule.

• It is expressed in atomic mass units (amu) or grams per mole (g/mol).

• For example, the molecular weight of water (H2O) is 18.015 g/mol (2*1.008 + 15.999).

Quality control is a process used to ensure that products or services meet specified requirements and standards.

• Quality control involves monitoring and testing products or services to identify defects or deviations from standards.

• It aims to prevent defects and ensure consistent quality throughout production.

• Examples include inspecting products on a production line, conducting quality audits, and analyzing customer feedback.

• Quality control also involves implementing corrective...read more

Pasteurisation is a process of heating food or beverages to a specific temperature to kill harmful microorganisms.

• Pasteurisation is commonly used in the dairy industry to kill bacteria in milk and other dairy products.

• The process involves heating the product to a temperature between 60-85 degrees Celsius for a specific period of time.

• This temperature is sufficient to kill most pathogenic bacteria while preserving the taste and nutritional value of the product.

• After heating, t...read more

I can join immediately with proper notice to my current employer.

• I can start within 2 weeks of receiving an offer.

• I will need to provide a standard notice period to my current employer.

• I am flexible and can discuss potential start dates during the interview process.

ICH stands for Intracerebral Hemorrhage, which is a type of stroke caused by bleeding within the brain tissue.

• ICH is a type of stroke where blood vessels within the brain rupture and cause bleeding.

• Common symptoms of ICH include sudden severe headache, weakness, numbness, or tingling on one side of the body, and difficulty speaking or understanding speech.

• Treatment for ICH may include medications to control blood pressure, surgery to remove the blood clot, or rehabilitation t...read more

LOD stands for Limit of Detection and LOQ stands for Limit of Quantification. They are important parameters in analytical chemistry.

• LOD is the lowest concentration of an analyte that can be reliably detected but not necessarily quantified.

• LOQ is the lowest concentration of an analyte that can be reliably measured and quantified with acceptable accuracy and precision.

• LOD is typically determined by the signal-to-noise ratio method, while LOQ is determined by the signal-to-noise...read more

The work culture at our company is collaborative, innovative, and focused on continuous improvement.

• Encourages teamwork and open communication

• Values creativity and new ideas

• Emphasizes learning and development opportunities

• Promotes a positive and inclusive environment

• Focuses on quality and efficiency in work processes