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20+ Echobooom Management & Entrepreneurial Solutions Interview Questions and Answers

Updated 23 Jun 2024

Q1. What is your USFDA audit exposure and what kind of compliance you have done.

Ans.

I have extensive USFDA audit exposure and have implemented various compliance measures.

  • I have been a part of multiple USFDA audits and have experience in handling them.

  • I have implemented compliance measures such as Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and Good Clinical Practices (GCP).

  • I have also ensured compliance with regulations such as 21 CFR Part 11 and 21 CFR Part 820.

  • In my previous role, I led a team that successfully passed a USFDA audi...read more

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Q2. Deviations observed and how you have handled the same during batch execution

Ans.

Handled deviations during batch execution by identifying root cause, implementing corrective actions, and documenting the process.

  • Identified root cause of deviation

  • Implemented corrective actions to prevent future deviations

  • Documented the deviation and corrective actions taken

  • Communicated the deviation and corrective actions to relevant stakeholders

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Q3. As an electrical engineer how to reduce breakdown in machines

Ans.

Regular maintenance, proper installation, and using high-quality components can reduce breakdown in machines.

  • Regular maintenance can prevent wear and tear on machines

  • Proper installation ensures that machines are set up correctly and reduces the risk of malfunctions

  • Using high-quality components can increase the lifespan of machines and reduce the risk of breakdowns

  • Implementing safety measures can prevent accidents that can damage machines

  • Monitoring machines for signs of wear a...read more

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Q4. What is CAPA for current market complaints?

Ans.

CAPA stands for Corrective and Preventive Action. It is a process used to investigate and address complaints in the current market.

  • CAPA is a systematic approach to identifying the root cause of a problem and taking corrective and preventive actions to prevent it from recurring.

  • It involves investigating the complaint, identifying the cause, implementing corrective actions, and monitoring the effectiveness of those actions.

  • Examples of CAPA include implementing new procedures, t...read more

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Q5. Did you draft market complaint investigation?

Ans.

Yes, I have drafted market complaint investigations.

  • I have experience drafting market complaint investigations for various clients.

  • I am familiar with the regulatory requirements and guidelines for such investigations.

  • One example of a market complaint investigation I drafted involved a product recall due to safety concerns.

  • I also worked on a market complaint investigation related to false advertising claims made by a competitor.

  • My investigations have always been thorough and w...read more

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Q6. What are the equipment sub class and classification according to unit operations.

Ans.

Equipment sub class and classification vary according to unit operations.

  • Equipment sub classes include mixing, separation, heat transfer, and reaction equipment.

  • Mixing equipment includes agitators, blenders, and mixers.

  • Separation equipment includes centrifuges, filters, and screens.

  • Heat transfer equipment includes heat exchangers and boilers.

  • Reaction equipment includes reactors and fermenters.

  • Classification is based on the type of unit operation, such as distillation or cryst...read more

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Q7. Level of changes what we can make while transfer a product from same scale.

Ans.

Changes made while transferring a product from same scale depend on various factors.

  • The level of changes depends on the type of product being transferred.

  • The level of changes also depends on the scale of transfer.

  • Changes can be made in packaging, labeling, and formulation.

  • Changes should be made while keeping in mind the regulatory requirements.

  • Changes should be made while ensuring the quality and safety of the product.

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Q8. What is OEE?, how does it calculate?

Ans.

OEE stands for Overall Equipment Effectiveness. It is a metric used to measure manufacturing productivity.

  • OEE takes into account three factors: availability, performance, and quality.

  • Availability measures the percentage of time the equipment is available for production.

  • Performance measures the speed at which the equipment is running compared to its maximum speed.

  • Quality measures the percentage of good quality products produced by the equipment.

  • OEE is calculated by multiplying...read more

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Q9. What are the things to take care while Risk assesment.

Ans.

Risk assessment requires careful consideration of potential hazards and their likelihood of occurrence.

  • Identify potential hazards

  • Assess the likelihood of occurrence

  • Evaluate the potential consequences

  • Consider the effectiveness of existing controls

  • Determine the level of risk

  • Develop and implement risk management strategies

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Q10. What is effectiveness of CAPA?

Ans.

CAPA is effective in identifying and correcting root causes of problems to prevent recurrence.

  • CAPA stands for Corrective and Preventive Action.

  • It is a systematic approach to problem-solving and quality improvement.

  • CAPA helps to identify the root cause of a problem and take corrective action to prevent recurrence.

  • It also helps to prevent potential problems by taking preventive action.

  • Effective CAPA implementation can lead to improved product quality, customer satisfaction, and...read more

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Q11. How you handel shift Operations?

Ans.

I handle shift operations by ensuring proper communication, delegation of tasks, and monitoring performance.

  • Maintain open communication with team members

  • Delegate tasks based on individual strengths and workload

  • Monitor performance and provide feedback for improvement

  • Ensure proper handover between shifts

  • Address any issues or concerns promptly

  • Maintain a positive and productive work environment

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Q12. Scale up factors while site transfer.

Ans.

Scale up factors are important during site transfer to ensure successful implementation.

  • Scale up factors refer to the considerations and adjustments needed when transferring a process or operation from one site to another.

  • Factors to consider include equipment capacity, process efficiency, resource availability, and regulatory compliance.

  • Examples of scale up factors include ensuring the new site has adequate space and infrastructure to accommodate the process, verifying that e...read more

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Q13. Types of qualification stages?

Ans.

Qualification stages can be categorized into three types.

  • Theoretical qualification stage

  • Practical qualification stage

  • Final qualification stage

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Q14. Breakdown & process maintenance of OSD.

Ans.

OSD stands for Oral Solid Dosage. It involves the breakdown and maintenance process of solid medications.

  • OSD refers to solid medications like tablets and capsules.

  • Breakdown process involves disintegration of the tablet or capsule in the gastrointestinal tract.

  • Maintenance process ensures the stability and effectiveness of the medication.

  • Examples include tablets that dissolve in the stomach to release the active ingredient.

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Q15. Detailed mfg process

Ans.

The manufacturing process involves multiple steps from raw material procurement to final product assembly.

  • Raw material procurement

  • Quality control checks

  • Production line assembly

  • Packaging and labeling

  • Final product inspection

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Q16. What is the Analytical method validation. ?

Ans.

Analytical method validation is the process of demonstrating that an analytical method is suitable for its intended use.

  • It involves testing the accuracy, precision, specificity, and robustness of the method.

  • Validation is necessary to ensure that the results obtained from the method are reliable and reproducible.

  • It is a requirement for regulatory compliance in industries such as pharmaceuticals and food.

  • Examples of analytical methods that require validation include HPLC, GC, a...read more

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Q17. Define CPP and CQA.

Ans.

CPP stands for Current Good Manufacturing Practice and CQA stands for Critical Quality Attributes.

  • CPP refers to the set of guidelines and regulations that ensure the quality and safety of pharmaceutical products during their manufacturing process.

  • CQA refers to the specific characteristics of a product that are critical to its quality and must be monitored and controlled during the manufacturing process.

  • CPP and CQA are both important concepts in the pharmaceutical industry to ...read more

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Q18. Working Principal of instruments

Ans.

Instruments work based on specific principles like measuring, detecting, or analyzing physical quantities.

  • Instruments operate based on physical principles such as electromagnetism, optics, or mechanics.

  • They convert physical quantities into measurable signals or data.

  • Examples include thermometers measuring temperature, spectrophotometers analyzing light absorption, and voltmeters detecting voltage.

  • Instruments may use sensors, transducers, or detectors to capture data and displ...read more

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I'm sorry, I don't understand the question.

  • Please clarify the question.

  • I'm not sure what you're asking.

  • Can you please provide more context?

  • I don't have enough information to answer this question.

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Q20. Troubleshooting in method validation.

Ans.

Troubleshooting in method validation involves identifying and resolving issues that arise during the validation process.

  • Identify the source of the problem

  • Review the validation protocol and ensure it is being followed correctly

  • Check equipment and reagents for accuracy and precision

  • Evaluate data and determine if it meets acceptance criteria

  • Make necessary adjustments and revalidate as needed

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Q21. How to handle Warehouse

Ans.

Warehouse management requires efficient planning, organization, and communication.

  • Create a system for inventory management and tracking

  • Ensure safety protocols are in place and followed

  • Train and supervise staff to maintain cleanliness and organization

  • Communicate effectively with other departments to ensure timely delivery of goods

  • Regularly review and analyze warehouse operations to identify areas for improvement

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Q22. Golden rules of accounts

Ans.

Golden rules of accounts are basic principles that guide the recording of financial transactions.

  • Debit the receiver, credit the giver

  • Debit what comes in, credit what goes out

  • Debit expenses and losses, credit income and gains

  • Debit assets, credit liabilities and equity

  • Debit the increase in assets, credit the decrease in assets

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