10+ QA Validation Interview Questions and Answers

Tests performed for autoclave include biological indicator testing, temperature mapping, and pressure testing.

• Biological indicator testing is done to ensure that the autoclave is effectively killing microorganisms.

• Temperature mapping is performed to ensure that the autoclave is maintaining the required temperature throughout the sterilization process.

• Pressure testing is conducted to verify that the autoclave is maintaining the necessary pressure for sterilization.

• Other tests ...read more

HVAC tests are tests conducted to ensure the proper functioning and efficiency of heating, ventilation, and air conditioning systems.

• HVAC tests involve checking the temperature control and distribution systems.

• Tests may include measuring airflow, checking for leaks, and inspecting ductwork.

• Performance tests are conducted to assess the overall efficiency and effectiveness of the HVAC system.

• Examples of HVAC tests include air balance testing, refrigerant charge verification, an...read more

Input and output logs are records of data entering and leaving a system. They are used for troubleshooting and auditing purposes.

• Input logs record data that enters a system, such as user input or data from another system.

• Output logs record data that leaves a system, such as responses to user requests or data sent to another system.

• These logs are used for troubleshooting issues with the system, as well as for auditing and compliance purposes.

• Examples of systems that use input ...read more

Tests performed for tunnel include connectivity, throughput, latency, and security.

• Connectivity tests ensure that the tunnel is properly established and data can be transmitted.

• Throughput tests measure the amount of data that can be transmitted through the tunnel in a given time period.

• Latency tests measure the delay between data being sent and received through the tunnel.

• Security tests ensure that the tunnel is secure and data cannot be intercepted or tampered with.

• Examples ...read more

GAMP categorisation refers to the different levels of software used in the pharmaceutical industry.

• GAMP stands for Good Automated Manufacturing Practice

• There are five categories of GAMP: Category 1, 2, 3, 4, and 5

• Each category has different requirements for validation and documentation

• Category 1 includes software that has no impact on product quality

• Category 5 includes software that has a direct impact on product quality

Explanation of span, spread and equilibrium time.

• Span refers to the duration of time over which a process or event occurs.

• Spread refers to the distribution of values or results within a given set of data.

• Equilibrium time is the time required for a system to reach a steady state or balance.

• For example, the span of a clinical trial may be several years, the spread of test results may vary widely, and the equilibrium time for a chemical reaction may be minutes or hours.

Automation flow for CSV validation involves identifying data sources, creating test cases, executing tests, and generating reports.

• Identify data sources and ensure data integrity

• Create test cases based on requirements and expected outcomes

• Execute tests using automation tools and scripts

• Validate results and identify any discrepancies

• Generate reports to document test results and findings

Equipment qualifications follow a defined flow to ensure compliance with regulations and standards.

• The first step is to define the equipment and its intended use.

• Next, the equipment is installed and tested to ensure it meets specifications.

• Operational qualifications are then performed to ensure the equipment functions correctly.

• Performance qualifications are conducted to ensure the equipment consistently produces accurate and reliable results.

• Finally, maintenance and calibrat...read more

I will take line clearance by following the standard operating procedures and ensuring that all necessary checks are completed before starting the process.

• I will review the batch record and ensure that all previous steps have been completed and documented

• I will visually inspect the equipment and the area to ensure that there are no residual materials or contaminants

• I will verify that all necessary materials and components are available and properly labeled

• I will perform a lin...read more

I have a strong interest in QA validation as it allows me to ensure the quality and accuracy of products and processes.

• I enjoy problem-solving and finding solutions to complex issues.

• I am detail-oriented and enjoy ensuring that all aspects of a product or process are thoroughly tested.

• I find satisfaction in knowing that my work contributes to the overall success of a project or company.

• For example, in my previous role as a QA analyst, I was responsible for testing a new softw...read more

Manpower handling involves effective communication, delegation, training, and motivation.

• Effective communication is key to ensure everyone is on the same page

• Delegation of tasks based on skills and expertise

• Training to improve skills and knowledge

• Motivation through recognition and rewards

• Regular performance evaluations to identify areas of improvement

Yes, I am familiar with Excel sheet.

• I have experience in creating and editing spreadsheets.

• I am proficient in using formulas and functions in Excel.

• I can use Excel for data analysis and visualization.

• I am familiar with Excel shortcuts and formatting options.

A tablet is a solid dosage form of medication that is compressed into a small, flat, and round shape.

• Tablets are one of the most commonly used forms of medication.

• They are made by compressing a mixture of active ingredients and excipients.

• Tablets can be coated to make them easier to swallow or to protect the active ingredients from degradation.

• They come in various shapes, sizes, and colors depending on the manufacturer and the medication.

• Examples of commonly used tablets incl...read more