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I applied via Referral and was interviewed in May 2024. There were 3 interview rounds.
OOT and OOS investigations are conducted to determine the root cause of results that are out of specification or out of trend.
Identify the OOT or OOS result
Isolate the sample for further testing
Investigate potential causes such as equipment malfunction or human error
Document findings and corrective actions taken
Review and approve investigation report
Surfactants are classified into four main types: anionic, cationic, nonionic, and amphoteric, each with specific limits and applications.
Anionic surfactants have a negatively charged head group and include sulfates, sulfonates, and carboxylates.
Cationic surfactants have a positively charged head group and are often used as fabric softeners or antimicrobial agents.
Nonionic surfactants have no charge and are commonly use...
RS method development involves creating and optimizing analytical methods for the analysis of raw materials and finished products.
RS method development includes selecting appropriate analytical techniques based on the properties of the sample.
It also involves optimizing parameters such as sample preparation, chromatographic conditions, and detection methods.
Examples of RS method development include developing HPLC meth...
SOP (Standard Operating Procedure) outlines the steps and guidelines for performing a specific task or process.
SOPs detail step-by-step instructions
Include safety precautions and quality control measures
Should be clear, concise, and easy to follow
May include diagrams, flowcharts, or checklists
Regularly reviewed and updated to reflect current best practices
Validation ensures the right product is being built, while verification ensures the product is being built right.
Validation confirms that the product meets the customer's requirements and needs.
Verification ensures that the product is being built according to the specifications and design.
Validation is about checking if we are building the right product, while verification is about checking if we are building the produ...
Data integrity refers to the accuracy, consistency, and reliability of data throughout its lifecycle.
Ensuring data is accurate and reliable
Preventing unauthorized access or changes to data
Maintaining consistency of data across systems
Implementing data validation processes
Regularly auditing data to ensure integrity
Significant changes refer to major modifications or transformations in a particular aspect or area.
Significant changes can include shifts in strategy, technology, personnel, or processes.
Examples of significant changes may include implementing a new software system, restructuring a department, or launching a new product line.
These changes often require careful planning, communication, and execution to ensure successful
Deviation management involves identifying, documenting, investigating, and resolving any deviations from standard procedures or specifications.
Deviation management is a process used to address any deviations from established procedures or specifications.
It involves documenting the deviation, investigating the root cause, and implementing corrective actions to prevent recurrence.
Examples of deviations include equipment ...
I handle incidents by remaining calm, assessing the situation, taking appropriate action, and following up to prevent future occurrences.
Remain calm and composed during the incident
Assess the situation to determine the severity and necessary actions
Take appropriate steps to address the incident effectively
Follow up to analyze the root cause and implement preventive measures
Communicate effectively with team members and
I applied via Walk-in
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I applied via Walk-in and was interviewed in Dec 2019. There was 1 interview round.
TFF is a measure of cash generated from operations, while CFF is a measure of cash generated from financing activities.
TFF stands for 'Total Funds From Operations' and measures the cash generated from a company's core business operations.
CFF stands for 'Cash Flow From Financing' and measures the cash generated from financing activities such as issuing stocks or bonds.
TFF is an important metric for evaluating a company'...
Risk assessment involves identifying potential risks and evaluating their likelihood and impact.
Identify potential risks and their likelihood of occurring
Evaluate the potential impact of each risk
Develop strategies to mitigate or manage identified risks
Regularly review and update risk assessments
Examples: financial risk assessment, cybersecurity risk assessment
I applied via Walk-in and was interviewed in Dec 2019. There were 3 interview rounds.
I applied via Referral and was interviewed before May 2020. There were 4 interview rounds.
ALCOA and ALCOA plus are data integrity principles used in regulated industries.
ALCOA stands for Attributable, Legible, Contemporaneous, Original, and Accurate.
ALCOA plus adds the principles of Complete, Consistent, Enduring, and Available.
These principles ensure that data is reliable, traceable, and can be reproduced.
They are commonly used in industries such as pharmaceuticals, biotech, and medical devices.
Examples of...
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Biocon Limited
Piramal Group
Wockhardt
Strides Pharma