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Amneal
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Validation is done by following guidelines and standards to ensure accuracy and reliability of data.
Follow industry standards and best practices for validation
Use validation tools and software to automate the process
Perform manual checks and reviews to ensure data accuracy
Document validation procedures and results for future reference
Regularly update validation processes to adapt to changing requirements
MACO value is the Minimum Acceptable Compliance Objective, used to determine the minimum level of compliance required in a system.
MACO value is calculated based on the specific requirements and regulations of the system or industry.
It is typically determined by assessing the potential risks and consequences of non-compliance.
MACO value helps set a baseline for acceptable compliance levels and guides decision-makin...
The limit of passive air monitoring varies in different grade areas. The endotoxin limit of WFI water is determined by regulatory guidelines.
The limit of passive air monitoring in grade A, B, C, D areas is determined by the classification of these areas according to regulatory guidelines.
Grade A areas have the strictest limits for particulate and microbial contamination, while grade D areas have the least stringen...
Yes
I have extensive experience in FDA activities and audit preparations.
I have successfully managed FDA inspections and audits, ensuring compliance with regulations and guidelines.
I have developed and implemented standard operating procedures (SOPs) to ensure adherence to FDA requirements.
I have conducted internal audits to identify areas of improvement and implemented corrective actions.
I have trained staff on FD...
I have extensive knowledge of FDA audits and have faced 5 audits in my previous role.
I have a deep understanding of FDA regulations and guidelines.
I am familiar with the audit process and requirements.
I have successfully managed and prepared for 5 FDA audits in my previous role.
I have experience in ensuring compliance with FDA regulations and addressing any audit findings.
I have implemented corrective actions base...
Biological indicators are used to monitor sterilization processes. Types include spore strips, spore suspensions, and self-contained biological indicators.
Spore strips: paper strips with spores that are placed in the sterilization process and then incubated to check for growth
Spore suspensions: liquid suspensions containing spores that are used to test sterilization processes
Self-contained biological indicators: c...
Process validation is a documented evidence that ensures consistent production of products meeting predetermined specifications.
Process validation provides a high degree of assurance for consistent product quality.
It involves establishing documented evidence that a specific process consistently produces products meeting predetermined specifications.
There are different types of process validation, including process...
Maintenance processes include preventive, corrective, predictive, and condition-based maintenance.
Preventive maintenance involves scheduled inspections and repairs to prevent equipment failure.
Corrective maintenance is performed after a failure has occurred.
Predictive maintenance uses data analysis to predict when maintenance is needed.
Condition-based maintenance involves monitoring equipment to detect signs of we...
Investigated a customer complaint regarding product quality issues
Conducted interviews with production staff to gather information
Analyzed production records and quality control data
Identified root cause of the quality issues as a supplier error
Implemented corrective actions to prevent future occurrences
I have over 5 years of experience in training and development, specializing in designing and delivering customized programs for various industries.
Designed and implemented training programs for new hires and existing employees
Utilized various instructional methods such as e-learning, workshops, and simulations
Collaborated with subject matter experts to ensure training content accuracy
Evaluated training effectiveness th...
I applied via Walk-in and was interviewed in Oct 2024. There were 2 interview rounds.
The critical parameter in FBE is the film build thickness, which affects the performance and durability of the coating.
Film build thickness is crucial for achieving the desired level of protection
It impacts the coating's adhesion, flexibility, and overall performance
Proper film build thickness ensures long-term durability and corrosion resistance
Measuring film build thickness accurately is essential for quality control
...
HS gun stands for high-speed gun and LD gun stands for low-dose gun in the context of industrial operations.
HS gun refers to a high-speed gun used for rapid and efficient operations.
LD gun refers to a low-dose gun used for operations requiring less power or intensity.
Examples include high-speed guns used in manufacturing processes and low-dose guns used in radiation therapy.
I appeared for an interview in Mar 2025, where I was asked the following questions.
pH stands for 'potential of Hydrogen' and measures the acidity or alkalinity of a solution, ranging from 0 to 14.
pH is a logarithmic scale used to specify the acidity or basicity of an aqueous solution.
A pH of 7 is considered neutral (e.g., pure water).
pH values below 7 indicate acidity (e.g., lemon juice has a pH of about 2).
pH values above 7 indicate alkalinity (e.g., baking soda has a pH of about 9).
The pH scale typ...
Titration is a quantitative chemical analysis method with various types, each suited for different reactions and analytes.
1. Acid-Base Titration: Involves neutralization reactions, e.g., titrating hydrochloric acid with sodium hydroxide.
2. Redox Titration: Involves oxidation-reduction reactions, e.g., titrating potassium permanganate with iron(II) sulfate.
3. Complexometric Titration: Used to determine metal ions, e.g.,...
TOC stands for Total Organic Carbon, a measure of organic compounds in water or soil, crucial for environmental monitoring.
TOC is used to assess water quality in environmental studies.
High TOC levels can indicate pollution or contamination in water sources.
In wastewater treatment, TOC levels help evaluate treatment efficiency.
TOC analysis is essential in pharmaceuticals to ensure product purity.
GC stands for Gas Chromatography, a technique used for separating and analyzing compounds in a mixture.
Gas Chromatography is widely used in chemistry for analyzing volatile substances.
It separates components based on their volatility and interaction with the column material.
Common applications include testing for pollutants in air and analyzing essential oils.
GC can be coupled with mass spectrometry (GC-MS) for more de...
I applied via Naukri.com and was interviewed in Jul 2024. There were 3 interview rounds.
I applied via Walk-in and was interviewed in Aug 2024. There were 2 interview rounds.
I appeared for an interview in Mar 2025, where I was asked the following questions.
I appeared for an interview in Feb 2025, where I was asked the following questions.
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