70+ QC Officer Interview Questions and Answers

As a QC Officer, my job responsibilities include sampling and testing of raw materials and finished goods using instruments like GC and HPLC. I follow GDP, GMP, GLP, and ensure data integrity. I also perform monthly calibration and troubleshoot instruments.

• Sampling and testing of raw materials and finished goods

• Handling instruments like GC and HPLC

• Following GDP, GMP, GLP, and ensuring data integrity

• Performing monthly calibration of instruments

• Troubleshooting instruments like ...read more

pH is a measure of acidity or alkalinity. UV spectroscopy is based on the absorption of UV light by molecules. Solutions can be prepared in various concentrations like normal, molar, ppm, ppb. Chemistry is the study of matter and its properties. Molality, molarity, and normality are concentration units in chemistry.

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

• UV spectroscopy involves measuring the absorption of ultraviolet...read more

pH is a measure of acidity or alkalinity in a solution. HPLC stands for High Performance Liquid Chromatography.

• pH is a numeric scale used to specify the acidity or alkalinity of a solution.

• It measures the concentration of hydrogen ions in a solution.

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

• HPLC is a technique used in analytical chemistry to separate, identify, and quantify components in a mixture.

• It uses a high-pressure liquid mobile p...read more

Cu acceptance criteria as per IP, B.P and USP pharmacopoeia.

• Copper acceptance criteria varies slightly between IP, B.P and USP pharmacopoeia.

• IP and B.P specify a minimum purity of 99.5% copper, while USP specifies a minimum purity of 99.0% copper.

• All three pharmacopoeias specify limits for impurities such as lead, iron, zinc, and nickel.

• For example, IP and B.P limit lead to 0.005%, while USP limits lead to 0.002%.

• The pharmacopoeias also specify limits for other parameters suc...read more

Answering questions related to GC and preparation of 1.0N solution of NaOH

• GC stands for Gas Chromatography and is used to separate and analyze compounds in a mixture

• The principle of GC is based on the partitioning of the sample between a stationary phase and a mobile phase

• Precautions of GC include avoiding contamination, using proper sample preparation techniques, and ensuring proper calibration of the instrument

• To prepare a 1.0N solution of NaOH, dissolve 40g of NaOH in 1 li...read more

The interview questions are related to chemistry and involve topics like neutralization reaction, pH meter, pH of soil and water, and chemical formulas of caustic acid and sulfuric acid.

• Neutralization reaction is a chemical reaction between an acid and a base that results in the formation of salt and water.

• A pH meter is an electronic device used to measure the acidity or alkalinity of a solution.

• The pH of soil and water varies depending on the location and other factors. For ...read more

Buffer solutions with known pH values are used for pH meter calibration.

• Buffer solutions with pH values of 4.01, 7.00, and 10.01 are commonly used for pH meter calibration.

• The choice of buffer solution depends on the pH range of the sample being tested.

• The buffer solutions should be stored properly and replaced regularly to ensure accurate calibration.

• Calibration should be performed before each use of the pH meter.

Acidity pH range is from 0 to 6.9.

• Acidity is measured on a pH scale from 0 to 14.

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

• Acidity pH range is important in various industries like food, pharmaceuticals, and cosmetics.

• Examples of acidic substances are lemon juice (pH 2), vinegar (pH 3), and stomach acid (pH 1-2).

Dissolution acceptance criteria is the predetermined limit of drug release from a dosage form.

• It is used to ensure the quality and consistency of the drug product.

• It is based on the drug's pharmacokinetics and therapeutic effect.

• It is determined through in vitro dissolution testing.

• Examples include: 80% of drug release within 30 minutes for immediate release tablets.

• Criteria may vary depending on the drug product and regulatory requirements.

Gas chromatography is a technique used to separate and analyze volatile compounds in a mixture.

• Gas chromatography involves the use of a stationary phase and a mobile phase.

• The stationary phase is a solid or liquid coating inside a column, while the mobile phase is a gas.

• The mixture is injected into the column, and as the mobile phase flows through, different compounds interact with the stationary phase at different rates.

• This separation allows for the identification and quant...read more

CAPA stands for Corrective and Preventive Action. Tablet is a solid dosage form of medication.

• CAPA is a process used to identify and address the root cause of a problem or non-conformance in a product or process.

• Tablet is a solid dosage form of medication that is compressed into a small, flat shape.

• Tablets can be coated or uncoated, and can be designed to release medication immediately or over a period of time.

• Tablets are commonly used to treat a variety of medical conditions...read more

Chemicals commonly used in chemistry labs include acids, bases, solvents, reagents, and indicators.

• Acids: hydrochloric acid, sulfuric acid, nitric acid

• Bases: sodium hydroxide, potassium hydroxide, ammonia

• Solvents: ethanol, acetone, water

• Reagents: iodine, bromine, silver nitrate

• Indicators: phenolphthalein, methyl orange, litmus

Various instruments are used in QC such as HPLC, GC, UV-Vis spectrophotometer, FTIR, etc.

• High Performance Liquid Chromatography (HPLC)

• Gas Chromatography (GC)

• Ultraviolet-Visible (UV-Vis) Spectrophotometer

• Fourier Transform Infrared (FTIR) Spectrometer

• Atomic Absorption Spectrophotometer (AAS)

• Karl Fischer Titrator

• pH Meter

• Viscometer

• Melting Point Apparatus

• Refractometer

pH is a measure of acidity or alkalinity of a solution. It ranges from 0 to 14, with 7 being neutral.

• pH stands for 'potential of hydrogen'

• It is measured on a scale of 0 to 14

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

• pH can be measured using pH paper, pH meter, or indicators like litmus paper

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

Oxidation is the loss of electrons and reduction is the gain of electrons.

• Oxidation involves the loss of electrons from an atom or molecule.

• Reduction involves the gain of electrons by an atom or molecule.

• Oxidation and reduction always occur together in a chemical reaction.

• Examples include rusting of iron (oxidation) and photosynthesis (reduction).

IS code stands for Indian Standard code and is a set of standards established by the Bureau of Indian Standards (BIS) for various products and services.

• IS 456:2000 - Code of practice for plain and reinforced concrete

• IS 2062:2011 - Specification of steel for general structural purposes

• IS 1343:2012 - Code of practice for prestressed concrete

• IS 1608:2005 - Mechanical testing of metals

• IS 302-2-24:1992 - Safety of household and similar electrical appliances

• IS 539:2001 - Method of ...read more

GC stands for Gas Chromatography. The principle of GC is based on the separation of components of a mixture by their distribution between a stationary phase and a mobile phase.

• GC separates components based on their boiling points and affinity for the stationary phase

• The stationary phase can be a solid or a liquid coated on a solid support

• The mobile phase is usually an inert gas such as helium or nitrogen

• The sample is injected into the GC column and is vaporized by the high te...read more

SST parameters and types, and difference between HPLC and UPLC.

• SST parameters include glucose, electrolytes, liver enzymes, and more.

• Types of SST include plain, gel, and clot activator.

• HPLC uses high pressure to separate compounds, while UPLC uses even higher pressure for faster separation.

• HPLC is better for larger molecules, while UPLC is better for smaller molecules.

• Both are used in pharmaceutical and biotech industries for drug development and quality control.

HPLC is a technique used in analytical chemistry to separate, identify, and quantify components in a mixture. Polar and nonpolar refer to the polarity of molecules.

• HPLC stands for High-Performance Liquid Chromatography.

• It is a widely used technique in pharmaceutical, chemical, and food industries.

• HPLC separates components in a mixture based on their interactions with a stationary phase and a mobile phase.

• The stationary phase is a solid or liquid material packed into a column,...read more

UV stands for ultraviolet and is a form of electromagnetic radiation. CGMP stands for current Good Manufacturing Practice.

• UV refers to a type of electromagnetic radiation with a wavelength shorter than that of visible light, commonly used for sterilization and disinfection.

• The principle of UV involves using UV light to disrupt the DNA of microorganisms, preventing them from reproducing.

• CGMP refers to regulations and guidelines set by regulatory agencies to ensure the quality ...read more

Calibration parameters for big HPLC are the specific values used to ensure accurate and precise measurements in high-performance liquid chromatography.

• Calibration parameters include retention time, peak width, peak area, and peak height.

• Retention time is the time it takes for a compound to travel through the HPLC column.

• Peak width is the measure of the width of a peak at its base.

• Peak area is the integrated area under a peak, which represents the amount of a compound present....read more

I prioritize based on urgency, assess available information, consult with team if needed, and make a quick decision.

• Prioritize based on urgency of the situation

• Assess available information quickly

• Consult with team members if needed

• Make a quick decision based on the information gathered

Cultures refer to the beliefs, customs, practices, and behaviors shared by a group of people.

• Cultures are learned and passed down from generation to generation.

• They include language, religion, food, clothing, art, music, and social norms.

• Cultures vary across different regions, countries, and ethnic groups.

• They influence individuals' values, attitudes, and behaviors.

• Examples of cultures include Western culture, Asian culture, African culture, etc.

Preparation of solutions like Normal, Molar, ppm, ppb, etc.

• Normal solutions are prepared by dissolving a known weight of solute in a known volume of solvent.

• Molar solutions are prepared by dissolving a known number of moles of solute in a known volume of solvent.

• ppm (parts per million) solutions are prepared by dissolving a known weight of solute in a known volume of solvent and expressing the concentration in parts per million.

• ppb (parts per billion) solutions are prepared b...read more

Instruments that require daily and monthly calibration depend on the type of instrument and its usage.

• Instruments used for critical measurements such as pH meters, balances, and thermometers require daily calibration.

• Instruments used for less critical measurements such as pipettes and spectrophotometers require monthly calibration.

• Calibration frequency also depends on the frequency of use and the manufacturer's recommendations.

• Calibration ensures accuracy and reliability of m...read more

HPLC stands for High Performance Liquid Chromatography. Its principle is based on the separation of components in a mixture using a stationary phase and a mobile phase.

• HPLC separates components based on their polarity and size

• It uses a stationary phase (column) and a mobile phase (solvent)

• The sample is injected into the column and the components are separated based on their interaction with the stationary phase and mobile phase

• The separated components are detected and analyze...read more

Gas Chromatography is a technique used to separate and analyze volatile compounds in a mixture.

• Gas Chromatography separates compounds based on their volatility and affinity for the stationary phase.

• It involves the use of a carrier gas to carry the sample through a column packed with a stationary phase.

• The compounds in the sample interact differently with the stationary phase, leading to separation.

• The separated compounds are detected and quantified using a detector, such as a...read more

Aromatic compounds have a cyclic structure with alternating double bonds, while aliphatic compounds have a linear structure without double bonds.

• Aromatic compounds are highly stable and have strong odors.

• Aliphatic compounds are less stable and have weaker odors.

• Examples of aromatic compounds include benzene, toluene, and naphthalene.

• Examples of aliphatic compounds include methane, ethane, and propane.

The code used in RMC refers to the various standards and regulations followed in the Quality Control (QC) process.

• ISO 9001:2015 - Quality Management System

• ISO 13485:2016 - Medical devices - Quality management systems

• FDA 21 CFR Part 820 - Quality System Regulation for medical devices

• ICH Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

• ASTM E2500 - Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manuf...read more

Abbott Healthcare is a global healthcare company that develops and markets pharmaceuticals, medical devices, and nutritional products.

• Abbott Healthcare has a presence in over 160 countries

• They have a diverse portfolio of products including branded generics, biosimilars, and over-the-counter medications

• Some of their popular products include Humira, Similac, and Pedialyte

• They have a strong focus on research and development, investing over $1.5 billion annually

• Abbott Healthcare ...read more

In case of food contamination, I would immediately isolate the contaminated product and inform the relevant authorities.

• Identify the source of contamination

• Isolate the contaminated product to prevent further spread

• Inform the relevant authorities such as the food safety department

• Conduct a thorough investigation to determine the cause of contamination

• Implement corrective actions to prevent future contamination

Various factors can affect the moisture of products.

• Environmental conditions such as temperature and humidity

• Packaging materials and their permeability to moisture

• Processing methods and equipment used

• Storage conditions and duration

• Ingredients and their moisture content

• Handling and transportation methods

• Product formulation and recipe

• Microbial activity and growth

• Product exposure to air and moisture

• Product size and shape

• Product density and porosity

pH is a measure of acidity or alkalinity of a solution on a scale of 0-14.

• pH stands for 'potential of hydrogen'

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

• pH is measured using a pH meter or pH paper

• pH plays an important role in various industries such as food, cosmetics, and pharmaceuticals

Significant change refers to a notable and impactful alteration or transformation.

• Significant change implies a substantial and meaningful shift in a particular context.

• It often involves a noticeable difference in quality, quantity, or impact.

• Examples of significant change can include major process improvements, breakthrough discoveries, or paradigm shifts.

• It is typically characterized by its importance, relevance, and long-lasting effects.

• Significant change can also refer to ...read more

Hydro testing can be checked by performing visual inspection, pressure testing, and leak testing.

• Perform visual inspection of the equipment before testing

• Perform pressure testing by filling the equipment with water and pressurizing it to the required level

• Check for leaks by observing any drops in pressure over a certain period of time

• Ensure that all safety measures are taken during the testing process

• Record all test results and compare them to the required standards

To join pharma companies, one can pursue relevant education, gain experience through internships or entry-level positions, network with industry professionals, and apply for job openings.

• Pursue relevant education in pharmaceutical sciences or related fields

• Gain experience through internships or entry-level positions in the pharmaceutical industry

• Network with industry professionals through events, conferences, and online platforms

• Stay updated with industry trends and advanceme...read more

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

• HPLC is based on the principle of separating components in a mixture using a liquid mobile phase and a solid stationary phase.

• It is commonly used in pharmaceutical, environmental, and food industries for analyzing compounds.

• HPLC instruments consist of a pump, injector, column, detector, and data analysis software.

• Examples of applications i...read more

Spectroscopy is the study of the interaction between matter and electromagnetic radiation.

• Spectroscopy involves the measurement of the intensity of light as a function of its wavelength or frequency.

• It is used to identify substances, determine their concentration, and study chemical reactions.

• Different types of spectroscopy include UV-Vis spectroscopy, infrared spectroscopy, and nuclear magnetic resonance spectroscopy.

• Spectroscopy is based on the principle that different mole...read more

Melting range is the temperature range at which a substance melts, while melting point is the temperature at which it fully melts.

• Melting range is a range of temperatures at which a substance starts to melt and finishes melting.

• Melting point is the temperature at which a substance fully melts and becomes a liquid.

• Melting range is usually wider than melting point.

• Melting range is affected by impurities in the substance.

• Example: The melting range of pure water is 0-100°C, while...read more

Handling and resolving issues with instruments used in QC work

• Regular calibration and maintenance of instruments

• Proper storage and handling to prevent damage

• Troubleshooting issues with instruments promptly

• Training staff on correct instrument usage

• Documenting any issues and solutions for future reference

The standard used in AAS is the atomic absorption standard.

• Atomic absorption standard is used to calibrate and validate the accuracy of AAS instruments.

• It helps in determining the concentration of elements in a sample by measuring the absorption of light at specific wavelengths.

• Common examples of atomic absorption standards include solutions of known concentrations of elements like copper, lead, and zinc.

Chemistry is the scientific study of matter, its properties, composition, and interactions.

• Chemistry is a branch of science that deals with the structure, properties, and transformations of substances.

• It involves studying the composition, behavior, and properties of atoms, molecules, and compounds.

• Chemistry is used to understand and explain the physical and chemical properties of matter.

• It plays a crucial role in various fields such as medicine, materials science, environment...read more

HPLC, GC, UV, and IR are all instruments used in analytical chemistry.

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

• GC stands for Gas Chromatography and is used to separate and analyze volatile compounds.

• UV stands for Ultraviolet-Visible Spectroscopy and is used to analyze the absorption and transmission of light by a sample.

• IR stands for Infrared Spectroscopy and is used to analyze the vibration...read more

CGMP stands for Current Good Manufacturing Practice, which are regulations enforced by the FDA to ensure the quality of pharmaceutical products. Sulfated ash is a test used to determine the amount of inorganic residue in a compound.

• CGMP stands for Current Good Manufacturing Practice, ensuring quality in pharmaceutical manufacturing processes

• Sulfated ash test measures the inorganic residue left after igniting a sample at high temperatures

• Sulfated ash test is important for dete...read more

Dealing with clients requires effective communication, understanding their needs, and providing quality service.

• Listen actively to their concerns and needs

• Communicate clearly and professionally

• Provide timely and accurate information

• Be responsive and available

• Build a relationship based on trust and respect

• Ensure quality service and follow-up

• Handle complaints and issues promptly and effectively

Solubility is the ability of a substance to dissolve in a solvent.

• Solubility is a physical property that describes how well a substance dissolves in a particular solvent.

• It is usually expressed as the maximum amount of solute that can dissolve in a given amount of solvent at a specific temperature and pressure.

• Solubility depends on factors such as the nature of the solute and solvent, temperature, and pressure.

• For example, sugar is highly soluble in water, but insoluble in oi...read more

CGMP stands for current good manufacturing practices, which are regulations enforced by the FDA to ensure the quality of pharmaceutical products. HPLC analysis is a technique used to separate, identify, and quantify components in a mixture.

• CGMP ensures that pharmaceutical products are consistently produced and controlled according to quality standards.

• HPLC analysis involves passing a liquid sample through a column filled with a stationary phase, separating the components base...read more