70+ QA Executive Interview Questions and Answers

The pass or fail criteria in Friability test Apparatus is based on the percentage of friable mass loss.

• The pass criteria is typically set at a maximum percentage of friable mass loss, such as 1% or 0.5%.

• If the actual percentage of friable mass loss is below the pass criteria, the test is considered a pass.

• If the actual percentage of friable mass loss exceeds the pass criteria, the test is considered a fail.

• The friability test apparatus measures the ability of tablets or granu...read more

Factors influencing tablet hardness include formulation, compression force, excipients, and manufacturing process.

• Formulation: The choice and concentration of active and inactive ingredients affect tablet hardness.

• Compression force: The force applied during tablet compression affects its hardness.

• Excipients: The use of binders, fillers, and disintegrants can impact tablet hardness.

• Manufacturing process: Factors like granulation technique and drying conditions can influence ta...read more

HACCP is a systematic approach to food safety, GMP and GHP are quality management systems, CCP is a critical control point.

• HACCP stands for Hazard Analysis and Critical Control Points, it is a preventive system to identify and control food safety hazards.

• GMP stands for Good Manufacturing Practices, it ensures that products are consistently produced and controlled according to quality standards.

• GHP stands for Good Hygiene Practices, it focuses on maintaining cleanliness and hy...read more

Parameters and lab tests for raw material inward quality checks

• Parameters for raw material inward quality checks include visual inspection, documentation review, and sampling

• Lab tests may include physical tests, chemical tests, and microbiological tests

• Physical tests can include measurements of size, weight, and density

• Chemical tests can include analysis of composition, purity, and pH levels

• Microbiological tests can include testing for microbial contamination and presence of ...read more

Handling customer complaints and final inspection for CCM and Fasteners standards

• Listen to the customer's complaint and empathize with their situation

• Investigate the issue thoroughly and identify the root cause

• Provide a timely and satisfactory resolution to the customer

• Ensure that the final inspection meets the CCM and Fasteners standards

• Implement corrective actions to prevent similar issues from occurring in the future

Bitumen is a viscous, black, and sticky material used in road construction. Bitumen emulsion is a mixture of bitumen and water.

• Bitumen is a petroleum product used as a binder in road construction

• Bitumen emulsion is a mixture of bitumen and water used for surface treatments

• Amines are organic compounds used as emulsifiers in bitumen emulsions

• Viscosity is the measure of a fluid's resistance to flow

• Softening point is the temperature at which bitumen becomes soft and pliable

Guidelines for process validation include establishing process parameters, conducting process performance qualification, and ongoing monitoring.

• Establish process parameters

• Conduct process performance qualification

• Ongoing monitoring

• Document all validation activities

• Ensure compliance with regulatory requirements

• Consider risk management principles

• Involve relevant stakeholders

Corrective Action and Preventive Action are two types of actions taken to address and prevent issues in a process or system.

• Corrective Action is taken to address an existing issue or problem in a process or system.

• Preventive Action is taken to prevent potential issues or problems from occurring in a process or system.

• Examples of Corrective Action include investigating the root cause of a defect and implementing a solution to prevent it from happening again.

• Examples of Prevent...read more

In the process of manufacturing oral solids, various steps are carried out to ensure quality and efficacy.

• Raw material testing and selection

• Granulation or blending of active ingredients and excipients

• Compression or encapsulation of the mixture into tablets or capsules

• Coating of tablets for protection and ease of swallowing

• Packaging and labeling of the final product

• Quality control testing at different stages

• Documentation and record-keeping

Physical properties in analytical chemistry refer to characteristics of substances that can be observed or measured without changing their composition.

• Physical properties include color, odor, density, melting point, boiling point, solubility, and conductivity.

• These properties help in identifying and characterizing substances in analytical chemistry.

• For example, the melting point of a compound can be used to confirm its identity by comparing it to known values.

• Another example ...read more

Validation is the process of ensuring that a system or product meets the specified requirements and standards.

• Types of validation include: functional validation, performance validation, security validation, usability validation, and compliance validation.

• Functional validation ensures that the system or product meets the functional requirements.

• Performance validation ensures that the system or product meets the performance requirements.

• Security validation ensures that the syst...read more

Direct inoculation and membrane filtration are microbiological techniques used for detecting and quantifying microorganisms in a sample.

• Direct inoculation involves adding a sample to a growth medium and incubating it to allow any microorganisms present to grow and form colonies.

• Membrane filtration involves filtering a sample through a membrane with a pore size small enough to trap microorganisms, which are then transferred to a growth medium and incubated.

• Both techniques are ...read more

21 CFR part 11 is a regulation by the FDA for electronic records and signatures. Data integrity refers to the accuracy and consistency of data. ALCOA stands for Attributable, Legible, Contemporaneous, Original, and Accurate. Cleaning validation is the process of ensuring that cleaning procedures effectively remove residues. Handling deviations involves documenting, investigating, and resolving any deviations from standard procedures. CAPA stands for Corrective and Preventive ...read more

In Selenium, popups and alerts can be handled using the Alert interface and switchTo() method.

• Use Alert interface to handle popups and alerts

• Switch to the alert using driver.switchTo().alert()

• Perform actions like accept(), dismiss(), getText() on the alert

Balance calibration is done by comparing the readings of the balance with known weights.

• Balance calibration involves comparing the readings of the balance with known weights.

• Known weights are placed on the balance and the readings are recorded.

• The readings are then compared to the expected values to determine if the balance is accurate.

• Adjustments can be made to the balance if necessary to ensure accurate readings.

• Regular calibration is important to maintain the accuracy of t...read more

Factors such as temperature, concentration, catalysts, and surface area can affect the rate of action.

• Temperature: Higher temperatures generally increase the rate of action as molecules move faster.

• Concentration: Higher concentrations of reactants can lead to more collisions and faster reactions.

• Catalysts: Catalysts can speed up reactions by providing an alternative pathway with lower activation energy.

• Surface area: Increasing the surface area of reactants can lead to more co...read more

Sampling quantity in process validation refers to the number of units or batches selected for testing to ensure the process is consistently producing quality products.

• Sampling quantity should be representative of the entire production process.

• It should be sufficient to provide statistically significant results.

• Guidelines typically recommend a minimum number of samples to be taken.

• For example, FDA guidelines may recommend sampling at least 3 batches for process validation.

ICH guidelines are a set of internationally recognized standards for the development, registration, and post-approval of pharmaceutical products.

• ICH stands for International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.

• ICH guidelines provide recommendations on various aspects of drug development, including quality, safety, efficacy, and multidisciplinary topics.

• Examples of ICH guidelines include Q1-Q14 guidelines, which cover topics su...read more

The guidelines currently used for cleaning validation include FDA guidelines, ICH guidelines, and USP guidelines.

• FDA guidelines outline the requirements for cleaning validation in the pharmaceutical industry.

• ICH guidelines provide a harmonized approach to cleaning validation for the pharmaceutical industry.

• USP guidelines offer standards for cleaning validation in the pharmaceutical industry.

• Cleaning validation guidelines ensure that equipment and facilities are cleaned proper...read more

Activators/inhibitors are substances that either increase or decrease the activity of a biological process or enzyme.

• Activators are substances that increase the activity of a biological process or enzyme.

• Inhibitors are substances that decrease the activity of a biological process or enzyme.

• Examples include enzyme activators like ATP and enzyme inhibitors like penicillin.

• Activators can bind to enzymes and increase their activity, while inhibitors can bind and block enzyme acti...read more

The manufacturing process involved multiple stages including raw material procurement, quality checks, production, packaging, and final inspection.

• Raw material procurement from approved vendors

• Quality checks at every stage of production

• Production process involved mixing, blending, and filling

• Packaging of finished products in appropriate containers

• Final inspection to ensure product meets quality standards

APQR is a quality document that summarizes the results of an annual product quality review.

• APQR stands for Annual Product Quality Review.

• It is a quality document required by regulatory authorities.

• APQR summarizes the results of an annual review of product quality.

• It includes data on manufacturing processes, analytical results, complaints, deviations, and other quality-related information.

• APQR helps identify trends, potential issues, and areas for improvement.

• It is an importan...read more

Moisture content of peanuts and dry fruits is an important quality parameter.

• Moisture content affects the shelf life and quality of peanuts and dry fruits.

• High moisture content can lead to microbial growth and spoilage.

• Moisture content is typically measured using methods like oven drying or moisture analyzers.

• For peanuts, the ideal moisture content is around 6-7%.

• Dry fruits like raisins should have a moisture content of around 15-18%.

CAPA stands for Corrective and Preventive Action. It is a process used to identify and address problems to prevent their recurrence.

• CAPA is a systematic approach to problem-solving that involves identifying the root cause of a problem, implementing corrective actions to address the immediate issue, and taking preventive actions to prevent the problem from happening again.

• Examples of CAPA include investigating a customer complaint about a product defect, identifying the root c...read more

Batch Manufacturing Record is a document containing detailed instructions for the production of a specific batch of a product.

• Contains information on raw materials used

• Includes manufacturing steps and equipment used

• Records batch number, date of production, and personnel involved

• Provides quality control checks and results

• Essential for ensuring consistency and traceability in production

HPLC and GC are analytical techniques used to separate, identify, and quantify components in a mixture.

• HPLC (High Performance Liquid Chromatography) is used for separating compounds in a liquid mixture based on their interaction with a stationary phase and a mobile phase.

• GC (Gas Chromatography) is used for separating compounds in a gas mixture based on their partitioning between a stationary phase and a mobile phase.

• Both techniques are commonly used in analytical chemistry fo...read more

I have 5 years of work experience in food safety management.

• Developed and implemented food safety programs and policies

• Conducted regular audits and inspections to ensure compliance with regulations

• Trained staff on food safety practices and procedures

• Investigated and resolved food safety incidents and complaints

• Collaborated with cross-functional teams to improve food safety measures

PPAP stands for Production Part Approval Process, a standardized process used in the automotive industry to ensure quality and consistency of parts.

• PPAP is a set of procedures and requirements that suppliers must follow to demonstrate that their parts meet the customer's specifications.

• It includes documentation such as design records, engineering change orders, and material certifications.

• PPAP also involves testing and validation of the parts, including dimensional measuremen...read more

Selenium locators are used to identify web elements on a web page in order to perform automated testing.

• Selenium locators include ID, Name, Class Name, Tag Name, Link Text, Partial Link Text, CSS Selector, and XPath.

• They are used in Selenium WebDriver to interact with web elements such as clicking buttons, entering text, etc.

• For example, driver.findElement(By.id("username")).sendKeys("testuser");

Suicidal enzyme is an enzyme that is activated in response to cellular stress or damage and triggers cell death.

• Suicidal enzymes play a role in programmed cell death (apoptosis).

• Examples include caspases, which are activated in response to DNA damage or other cellular stressors.

• These enzymes help maintain cellular homeostasis by eliminating damaged or infected cells.

To grow in your career, focus on continuous learning, networking, taking on new challenges, and seeking feedback.

• Identify your strengths and areas for improvement

• Set clear goals and create a plan to achieve them

• Take on new projects and responsibilities to gain experience

• Network with colleagues and industry professionals

• Seek feedback from supervisors and peers to improve performance

• Invest in continuous learning through training, certifications, and conferences

HPLC is used to determine the presence and quantity of various substances in a sample.

• HPLC stands for High Performance Liquid Chromatography.

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

• HPLC separates and analyzes compounds in a sample based on their interactions with a stationary phase and a mobile phase.

• It is a powerful tool for identifying and quantifying components in complex mixtures.

• Examples of substances analyzed by HPLC include drugs, pest...read more

The culture of micro lab has a significant impact on the quality of testing and results.

• The culture should prioritize accuracy and precision in testing.

• There should be a strong emphasis on following protocols and procedures.

• Open communication and collaboration among lab members is crucial.

• Continuous training and education should be provided to keep up with advancements.

• The lab should have a culture of accountability and responsibility.

• Examples: A lab with a culture of rushing...read more

Smoke testing is a subset of regression testing, focusing on basic functionality, while sanity testing is a narrow regression testing, focusing on specific areas.

• Smoke testing is done to ensure the stability of the system before proceeding with detailed testing.

• Sanity testing is done to verify that specific functionality works as expected after changes.

• Smoke testing is a broader approach, covering major functionalities.

• Sanity testing is a narrower approach, focusing on specif...read more

Cleaning validation process ensures that cleaning procedures effectively remove residues from equipment and surfaces.

• Cleaning validation is a documented process to demonstrate that cleaning procedures are effective in removing residues.

• It involves establishing acceptance criteria, selecting appropriate sampling methods, and performing analytical testing.

• The process includes cleaning verification, which confirms that cleaning procedures are followed correctly.

• Cleaning validati...read more

MSCR and Jnr are not commonly used terms in the QA field.

• MSCR could potentially refer to a Medical Safety Case Report, but this is not a widely recognized acronym in the QA field.

• Jnr could refer to Junior, but it is unclear how this relates to QA.

• Without more context, it is difficult to provide a more specific answer.

Area qualifications refer to the specific skills and knowledge required for a particular job or industry.

• Area qualifications are often listed in job postings and include both technical and soft skills.

• Examples of area qualifications for a software developer may include proficiency in programming languages, knowledge of software development methodologies, and strong problem-solving skills.

• Area qualifications may also include certifications or licenses required for certain prof...read more

Process validation is the documented evidence that a process is consistently producing a product that meets predetermined specifications and quality attributes.

• Process validation is a critical component of quality assurance in manufacturing.

• It involves establishing documented evidence that a process is capable of consistently producing a product that meets predetermined specifications and quality attributes.

• Process validation typically involves three stages: process design, p...read more

I address complaints by listening to the concerns, investigating the issue, finding a resolution, and following up with the complainant.

• Listen actively to the complaint and show empathy towards the complainant.

• Investigate the issue thoroughly to understand the root cause.

• Find a resolution that satisfies the complainant and prevents future occurrences.

• Follow up with the complainant to ensure their satisfaction with the resolution.

• Document the complaint and resolution for futur...read more

Analytical chemistry is the branch of chemistry that deals with the analysis of substances to determine their composition and properties.

• It involves techniques such as spectroscopy, chromatography, and mass spectrometry.

• Analytical chemistry is used in various industries such as pharmaceuticals, environmental monitoring, and food testing.

• It plays a crucial role in quality control, research, and development processes.

• Analytical chemists work to identify and quantify the chemica...read more

Enzymes are biological molecules that act as catalysts to speed up chemical reactions in living organisms.

• Enzymes are proteins that are made up of long chains of amino acids.

• They work by lowering the activation energy needed for a chemical reaction to occur.

• Enzymes are specific to the reactions they catalyze, often referred to as lock and key model.

• Examples include amylase breaking down starch into sugars and catalase breaking down hydrogen peroxide into water and oxygen.

Titration is a technique used in chemistry to determine the concentration of a substance in a solution.

• Titration involves slowly adding a solution of known concentration to a solution of unknown concentration until the reaction reaches its endpoint.

• The endpoint is usually indicated by a color change or other observable change.

• Titration is commonly used in analytical chemistry to determine the concentration of acids, bases, and other substances in a solution.

• Examples of titrat...read more

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

• Ensuring data is accurate and reliable

• Maintaining consistency of data

• Preventing unauthorized access or modifications

• Implementing data validation processes

• Examples: Using checksums to verify data integrity, encryption to protect data from unauthorized changes

New implementation in FSSC V5.1 involves updates and changes to the Food Safety System Certification standard.

• Implementation of new requirements for food safety management systems

• Enhanced focus on risk management and communication

• Integration of ISO 22000:2018 requirements

• Training and awareness programs for employees

• Regular audits and assessments to ensure compliance

Quality culture refers to the shared values, beliefs, and behaviors within an organization that prioritize quality in all aspects of work.

• Quality culture is established through leadership commitment to quality standards and continuous improvement.

• It involves fostering a mindset of accountability and responsibility for quality outcomes among all employees.

• Encouraging open communication, collaboration, and a focus on customer satisfaction are key components of a quality culture...read more

Priority determines the order in which issues should be fixed, while severity indicates the impact of the issue on the system.

• Priority is based on business needs and impact on project timeline.

• Severity is based on the impact of the issue on the system functionality.

• Priority can change based on project requirements, while severity remains constant.

• Example: A spelling mistake in a button label may have low severity but high priority if it affects user experience.

• Example: A crit...read more

Quality plays a critical role in ensuring the sterility and safety of products in aseptic areas.

• Ensuring compliance with regulatory requirements for aseptic processing

• Implementing and monitoring aseptic techniques and procedures

• Performing regular environmental monitoring to detect any contamination

• Training personnel on proper aseptic practices

• Investigating and addressing any deviations or failures in aseptic processes