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Tailing factor is a measure of the efficiency of a chromatographic column.
Tailing factor is calculated as the distance between the peak maximum and the baseline divided by twice the standard deviation of the peak.
A tailing factor of 1 indicates a symmetrical peak, while values greater than 1 indicate tailing and less than 1 indicate fronting.
Tailing factor is important in chromatography to assess the quality of se...
Robustness refers to the ability of a system to remain stable and functional under varying conditions or stress.
Robustness is the ability of a system to handle unexpected inputs or disturbances without crashing or failing.
It involves designing systems to be resilient and able to recover from errors or failures.
For example, a robust computer program should be able to handle invalid user inputs without crashing.
In e...
Accuracy is the degree of closeness of a measured or calculated quantity to its actual (true) value.
Accuracy is a measure of how close a measurement is to the true value.
It is important in various fields such as science, engineering, and statistics.
For example, in shooting sports, accuracy refers to how close a shot is to the target center.
In data analysis, accuracy is used to evaluate the performance of a predict...
Buffers are solutions that resist changes in pH when small amounts of acid or base are added.
Buffers are typically made up of a weak acid and its conjugate base, or a weak base and its conjugate acid
Common examples of buffers include acetic acid and acetate ion, or ammonia and ammonium ion
Buffers are important in maintaining stable pH levels in biological systems
ALCOA principle is a guideline for ensuring data integrity in regulated industries, emphasizing data should be attributable, legible, contemporaneous, original, and accurate.
Attributable - Data should be traceable to its source.
Legible - Data should be clear and easy to read.
Contemporaneous - Data should be recorded at the time of observation.
Original - Data should be the first recording of the information.
Accurat...
APQR Preparation requirements include data collection, analysis, and documentation of product quality review.
Collecting data on product quality and performance
Analyzing the data to identify trends and areas for improvement
Documenting the findings and actions taken in a report
Ensuring compliance with regulatory requirements
Involving cross-functional teams in the review process
Regularly reviewing and updating the AP...
Validation ensures that a process or system meets the intended requirements and specifications, while qualification ensures that the equipment or system is installed and operates correctly.
Validation is about ensuring that the process or system meets the intended requirements and specifications.
Qualification is about ensuring that the equipment or system is installed and operates correctly.
Validation is focused on...
Critical parameters of manufacturing are the key factors that affect the quality and consistency of the final product.
Critical parameters are specific to each manufacturing process and product.
They include factors such as temperature, pressure, humidity, and time.
Monitoring and controlling critical parameters is essential to ensure product quality and consistency.
Examples of critical parameters in pharmaceutical m...
Guidelines for validation of autoclave and tunnel
Autoclave validation should follow guidelines from ISO 17665-1 and PDA Technical Report No. 1
Tunnel validation should follow guidelines from PDA Technical Report No. 39
Validation should include physical and biological indicators
Physical indicators include temperature, pressure, and time
Biological indicators include spore strips or ampoules
Validation should be perfor...
CPP stands for Certified Pharmaceutical Professional and CQA stands for Certified Quality Auditor.
CPP is a certification for professionals working in the pharmaceutical industry, demonstrating their knowledge and expertise in various areas such as drug development, manufacturing, and quality control.
CQA is a certification for professionals involved in quality assurance and auditing, ensuring that products, process...
As a Quality Assurance professional, I aim to ensure product quality through testing, documentation, and process improvement.
Conduct thorough testing of software applications to identify defects and ensure functionality meets requirements.
Develop and maintain test plans, test cases, and test scripts to ensure comprehensive coverage of application features.
Collaborate with development teams to understand requirements an...
I have extensive experience in Quality Assurance, focusing on process improvement and defect reduction in software development.
Led a QA team in implementing automated testing, reducing testing time by 30%.
Developed and executed test plans for multiple projects, ensuring 95% defect detection before release.
Collaborated with cross-functional teams to enhance product quality, resulting in a 20% increase in customer satisf...
Buffers are solutions that resist changes in pH when small amounts of acid or base are added.
Buffers are typically made up of a weak acid and its conjugate base, or a weak base and its conjugate acid
Common examples of buffers include acetic acid and acetate ion, or ammonia and ammonium ion
Buffers are important in maintaining stable pH levels in biological systems
Tailing factor is a measure of the efficiency of a chromatographic column.
Tailing factor is calculated as the distance between the peak maximum and the baseline divided by twice the standard deviation of the peak.
A tailing factor of 1 indicates a symmetrical peak, while values greater than 1 indicate tailing and less than 1 indicate fronting.
Tailing factor is important in chromatography to assess the quality of separat...
Accuracy is the degree of closeness of a measured or calculated quantity to its actual (true) value.
Accuracy is a measure of how close a measurement is to the true value.
It is important in various fields such as science, engineering, and statistics.
For example, in shooting sports, accuracy refers to how close a shot is to the target center.
In data analysis, accuracy is used to evaluate the performance of a predictive m...
Robustness refers to the ability of a system to remain stable and functional under varying conditions or stress.
Robustness is the ability of a system to handle unexpected inputs or disturbances without crashing or failing.
It involves designing systems to be resilient and able to recover from errors or failures.
For example, a robust computer program should be able to handle invalid user inputs without crashing.
In engine...
ALCOA principle is a guideline for ensuring data integrity in regulated industries, emphasizing data should be attributable, legible, contemporaneous, original, and accurate.
Attributable - Data should be traceable to its source.
Legible - Data should be clear and easy to read.
Contemporaneous - Data should be recorded at the time of observation.
Original - Data should be the first recording of the information.
Accurate - D...
I applied via Referral and was interviewed in Mar 2024. There were 3 interview rounds.
In my previous roles, I focused on quality assurance, process improvement, and compliance in software development.
Conducted thorough testing of software applications to ensure functionality and performance.
Developed and maintained test plans and test cases based on project requirements.
Collaborated with cross-functional teams to identify and resolve defects.
Implemented automated testing tools to enhance efficiency and ...
Related job roles and work culture
I applied via Referral and was interviewed before Mar 2023. There were 2 interview rounds.
I applied via Company Website
I applied via Approached by Company and was interviewed in Mar 2022. There were 2 interview rounds.
Answering questions related to instruments handling, software usage, calibration, and AMC.
Handled various instruments such as HPLC, GC, KF, etc.
Worked with software like Empower, Chromeleon, etc.
Calibration of instruments involves checking and adjusting the accuracy of the instrument using standard solutions.
AMC stands for Annual Maintenance Contract, which is a service agreement between the instrument manufacturer and...
I applied via Naukri.com and was interviewed before Dec 2021. There were 2 interview rounds.
APQR Preparation requirements include data collection, analysis, and documentation of product quality review.
Collecting data on product quality and performance
Analyzing the data to identify trends and areas for improvement
Documenting the findings and actions taken in a report
Ensuring compliance with regulatory requirements
Involving cross-functional teams in the review process
Regularly reviewing and updating the APQR as...
CPP stands for Certified Pharmaceutical Professional and CQA stands for Certified Quality Auditor.
CPP is a certification for professionals working in the pharmaceutical industry, demonstrating their knowledge and expertise in various areas such as drug development, manufacturing, and quality control.
CQA is a certification for professionals involved in quality assurance and auditing, ensuring that products, processes, a...
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