80+ 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

The auditor's name was John Smith. He observed discrepancies in the documentation process and lack of adherence to quality standards.

• Auditor's name: John Smith

• Observations: Discrepancies in documentation process, lack of adherence to quality standards

• Explanation: Implemented new documentation protocols, conducted training sessions for staff

Reconciliation in BMR is the process of comparing the actual quantities of materials used in production with the expected quantities.

• Reconciliation involves comparing the actual quantities of raw materials, intermediates, and finished products used in production with the quantities specified in the BMR.

• Discrepancies between actual and expected quantities are investigated to determine the cause and ensure product quality.

• Reconciliation calculations are typically done by compar...read more

Handling problem, SPC, MSA, IATF, GD&T, Inspection instruments requires a systematic approach.

• Understand the problem and its root cause

• Use statistical process control (SPC) to monitor and control the process

• Conduct measurement system analysis (MSA) to ensure accuracy of inspection instruments

• Adhere to International Automotive Task Force (IATF) standards for quality management

• Use Geometric Dimensioning and Tolerancing (GD&T) to ensure proper design and manufacturing

• Regularly c...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

QA executive plays a crucial role in media fill validation, environmental monitoring, change controls, and deviations.

• Media fill validation ensures that the filling process is free from contamination.

• Environmental monitoring helps to identify potential sources of contamination.

• QA change controls ensure that any changes made to the process are properly documented and reviewed.

• QA deviations help to identify and address any issues that arise during the filling process.

• Past job r...read more

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

I have 5 years of experience implementing HACCP in food manufacturing industry.

• Led HACCP team in developing and implementing HACCP plans

• Conducted hazard analysis and identified critical control points

• Established monitoring procedures and corrective actions

• Trained staff on HACCP principles and procedures

• Successfully passed HACCP audits and maintained compliance

GMP in the food industry refers to Good Manufacturing Practices, which are guidelines and regulations set to ensure the safety and quality of food products.

• GMP includes practices such as proper sanitation, employee training, equipment maintenance, and record-keeping to prevent contamination and ensure product consistency.

• Examples of GMP in the food industry include regular cleaning of equipment, monitoring of temperature and humidity levels, and strict adherence to recipe for...read more

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

HACCP is a systematic approach to food safety, while QA focuses on preventing issues and QC focuses on identifying and fixing issues.

• HACCP stands for Hazard Analysis and Critical Control Points, a systematic approach to food safety

• QA (Quality Assurance) focuses on preventing issues through processes and procedures

• QC (Quality Control) focuses on identifying and fixing issues through testing and inspections

• QA is proactive, while QC is reactive

• Example: QA would involve setting u...read more

I have encountered various audits including internal audits, supplier audits, and regulatory audits.

• Internal audits to ensure compliance with company policies and procedures

• Supplier audits to assess the quality of products or services provided by vendors

• Regulatory audits to verify compliance with industry regulations and standards

QMS is a systematic approach to managing quality throughout an organization's processes.

• Establishing quality objectives and policies

• Implementing quality control measures

• Conducting regular audits and reviews

• Continuous improvement through corrective and preventive actions

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

Site Master File is a document containing detailed information about the manufacturing site and its operations.

• Site Master File is a comprehensive document that provides detailed information about the manufacturing site, including its facilities, equipment, personnel, and quality management systems.

• It serves as a reference document for regulatory authorities to assess the site's compliance with Good Manufacturing Practices (GMP).

• Guidelines for creating a Site Master File incl...read more

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

PDQA stands for Product Data Quality Assurance.

• PDQA stands for Product Data Quality Assurance.

• It is a process of ensuring the accuracy, completeness, and consistency of product data.

• Examples of PDQA activities include data validation, data cleansing, and data profiling.

The audit process involves planning, conducting fieldwork, reporting findings, and following up on corrective actions.

• Planning phase includes defining objectives, scope, and criteria for the audit.

• Conducting fieldwork involves gathering evidence, analyzing data, and evaluating processes.

• Reporting findings includes documenting observations, conclusions, and recommendations.

• Following up on corrective actions involves monitoring implementation of recommendations and verifying ef...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%.

SOP structure includes title, purpose, scope, responsibilities, procedures, references, and definitions.

• Title: Clearly states the purpose of the SOP.

• Purpose: Describes the reason for creating the SOP.

• Scope: Defines the boundaries and limitations of the SOP.

• Responsibilities: Outlines who is responsible for following the SOP.

• Procedures: Details the step-by-step instructions to be followed.

• References: Lists any documents or resources used in creating the SOP.

• Definitions: Provide...read more

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

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

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

CAPA stands for Corrective and Preventive Actions in the pharmaceutical industry.

• CAPA is a systematic approach to identifying and addressing root causes of quality issues.

• Corrective actions are taken to eliminate the cause of nonconformities, while preventive actions are taken to prevent recurrence.

• Examples of CAPA include investigating customer complaints, conducting root cause analysis, implementing corrective actions, and monitoring effectiveness.

• CAPA is a key component of...read more

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