Shilpa Medicare
40+ Interview Questions and Answers
Q1. During Compression Line Clearance, if the weight of the Blend is less than the Given Limit,as a IPQA what is ur Action
If the weight of the Blend is less than the Given Limit during Compression Line Clearance, the IPQA should take appropriate action.
The IPQA should immediately stop the compression process.
They should inform the production team and supervisor about the issue.
Investigate the cause of the weight discrepancy, such as equipment malfunction or incorrect formulation.
Document the incident and any observations made during the process.
Take necessary corrective actions to ensure the ble...read more
Q2. How do you convert reverphase to normal phase in hplc
To convert reverse phase to normal phase in HPLC, change the stationary phase from non-polar to polar.
Replace the non-polar stationary phase with a polar one
Use a polar mobile phase
Adjust the pH of the mobile phase to match the pKa of the analyte
Optimize the gradient elution conditions
Verify the separation using appropriate standards
Q3. What is the time lines for CEP approvals
CEP approval timelines vary depending on the complexity of the application and the workload of the EDQM.
CEP applications are reviewed by the European Directorate for the Quality of Medicines (EDQM)
The review process can take anywhere from 6 to 18 months
The complexity of the application and workload of the EDQM can affect the timeline
CEP approvals are valid for 5 years and can be renewed
CEPs are recognized by regulatory authorities in over 40 countries
Q4. Which guidelines followed for nitrosami e limits
The guidelines followed for nitrosamine limits are set by regulatory agencies such as FDA, EMA, and ICH.
Nitrosamine limits are set by regulatory agencies to ensure the safety of pharmaceutical products.
FDA has set a limit of 96 ng/day for nitrosamines in certain medications.
EMA has set a limit of 26.5 ppm for nitrosamines in sartan medicines.
ICH has issued guidelines for the detection and control of nitrosamines in pharmaceuticals.
Q5. Definition of boiling point, types of agitator, types of reactor, cGMP, change control, function of Quality control, CoA, handling of reactor,centrifuge, dryer,filter,multimill, sifter etc
The question covers topics related to process engineering in production, including boiling point, types of equipment, cGMP, change control, quality control, and handling of various equipment.
Boiling point is the temperature at which a substance changes from a liquid to a gas.
Types of agitators include paddle agitators, anchor agitators, and turbine agitators.
Types of reactors include batch reactors, continuous stirred tank reactors, and plug flow reactors.
cGMP stands for curr...read more
Q6. How to set in gun to bed
Setting a gun to bed involves safely storing and securing the firearm.
Unload the gun and remove any ammunition
Store the gun in a locked safe or cabinet
Keep the gun and ammunition separate
Use trigger locks or cable locks for added security
Follow local laws and regulations regarding gun storage
Q7. What u know about fermentation, chromatography technique...?
Fermentation is a process of converting sugars into alcohol or organic acids. Chromatography is a technique used to separate and analyze mixtures.
Fermentation is used in the production of alcoholic beverages like beer and wine.
It is also used in the production of bread, yogurt, and cheese.
Chromatography is used in the separation and purification of complex mixtures like proteins and DNA.
It is used in various fields like pharmaceuticals, forensics, and environmental testing.
Th...read more
Q8. What are the protection are need full for power transformer
Power transformers require various protection measures to ensure their safe and reliable operation.
Overcurrent protection to prevent excessive current flow
Differential protection to detect internal faults
Buchholz relay to detect and prevent transformer oil and gas faults
Temperature monitoring to prevent overheating
Voltage protection to safeguard against overvoltage
Ground fault protection to detect and isolate ground faults
Winding temperature indicators to monitor winding temp...read more
Q9. Pan Rpm how to increase
To increase pan RPM, adjust the speed control settings, increase power input, or optimize the pan's weight distribution.
Check the speed control settings and increase the RPM limit if necessary.
Increase the power input to the pan by adjusting the power supply or using a more powerful motor.
Optimize the weight distribution of the pan by redistributing the load or using counterweights.
Ensure that the pan is properly lubricated to reduce friction and allow for smoother rotation.
Q10. How many size of Coating pan
The number of sizes of coating pans varies depending on the manufacturer and specific requirements.
The number of sizes of coating pans can range from a few standard sizes to a wide range of options.
Manufacturers may offer coating pans in sizes such as 12 inches, 18 inches, 24 inches, etc.
The size of the coating pan is determined by the capacity and the desired batch size of the coating process.
Different sizes of coating pans may be used for different applications or productio...read more
Q11. which type class CT can we use diffential protection
We can use a Class CT for differential protection.
Class CTs are commonly used for differential protection in electrical engineering.
Class CTs provide accurate current measurement and can detect small differences in current flow.
They are often used in applications such as transformer differential protection and motor protection.
Class CTs are designed to have a high accuracy and low saturation level to ensure reliable differential protection.
Examples of Class CTs commonly used ...read more
Q12. Negative pressure how to set
Negative pressure is set by adjusting the airflow in a controlled environment.
Negative pressure is created by ensuring that the exhaust airflow is greater than the supply airflow.
This can be achieved by adjusting dampers or vents to control the airflow.
Negative pressure is commonly used in environments like cleanrooms, isolation rooms, or laboratories to prevent the spread of contaminants.
For example, in a hospital isolation room, the exhaust fan is set to a higher speed than...read more
Q13. Flow given water, methanol and isopropanol
The flow of water, methanol, and isopropanol can be determined by measuring their respective viscosities and densities.
Viscosity and density of each liquid must be measured
The flow rate can be calculated using the Hagen-Poiseuille equation
The flow rate will vary depending on the pipe diameter and pressure
The flow rate can be optimized by adjusting the pipe diameter and pressure
The flow rate of each liquid can be compared to ensure consistency
Q14. Which is the magic solution
There is no magic solution.
There is no one-size-fits-all solution for quality control.
Quality control requires a combination of various techniques and processes.
Continuous improvement and adaptation are key in quality control.
Examples of quality control techniques include statistical process control, Six Sigma, and Lean manufacturing.
Q15. Spray pump increase to problems
Spray pump increase can lead to various problems.
Increased spray pump pressure can cause leaks or bursts in the system.
Higher pump pressure can result in excessive spray application, leading to wastage of resources.
Increased pump pressure may cause uneven spray distribution, resulting in poor coverage.
Higher pump pressure can also lead to increased wear and tear on the pump components, reducing its lifespan.
Excessive pump pressure can cause damage to delicate surfaces or plan...read more
Q16. What is meant by HVAC ?
HVAC stands for Heating, Ventilation, and Air Conditioning.
HVAC is a system used to control the temperature, humidity, and air quality in a building.
It includes heating, cooling, ventilation, and air filtration systems.
HVAC systems are commonly used in residential, commercial, and industrial buildings.
Examples of HVAC equipment include air conditioners, furnaces, boilers, and ductwork.
Proper maintenance of HVAC systems is important for energy efficiency and indoor air quality...read more
Q17. Current trend of deficiencies.
Deficiencies in regulatory compliance are increasing due to stricter regulations and increased scrutiny.
Stricter regulations are being implemented by regulatory bodies
Increased scrutiny by regulatory bodies
Non-compliance with regulations due to lack of understanding or resources
Increased focus on data integrity and quality
Increased emphasis on risk management
Examples include FDA warning letters for data integrity issues and EU MDR non-compliance
Q18. How we are suitable for position
I have extensive experience in leadership roles and a proven track record of successfully managing teams and achieving targets.
Strong leadership skills demonstrated through previous roles
Proven track record of meeting and exceeding targets
Excellent communication and interpersonal skills
Ability to motivate and inspire team members
Experience in strategic planning and decision-making
Q19. Calibration Frequency of Critical & Non-Critical Instruments
Critical instruments should be calibrated more frequently than non-critical instruments to ensure accuracy and reliability.
Critical instruments should be calibrated at least once a month or as recommended by the manufacturer.
Non-critical instruments can be calibrated less frequently, such as once a year.
Regular calibration ensures accurate measurements and reliable performance of instruments.
Examples: Critical instruments may include temperature sensors in a pharmaceutical ma...read more
Q20. Way use in Spray patran
Spray pattern is used to achieve uniform coverage and efficient application of a substance.
Spray pattern helps in evenly distributing the substance being sprayed.
It ensures that the substance reaches the desired target area effectively.
Different spray patterns can be used depending on the application requirements.
Examples of spray patterns include fan, cone, flat, and mist patterns.
Q21. What is qualification and validation What cararonator
Qualification and validation are two important processes in ensuring the quality and reliability of products and processes.
Qualification is the process of demonstrating that equipment or systems are suitable for their intended use.
Validation is the process of establishing documented evidence that a process or system consistently produces a product or result that meets predetermined specifications and quality attributes.
Qualification and validation are often required in regula...read more
Q22. Pan increase in problems
The pan increase in problems refers to a sudden surge in the number of issues or challenges.
There has been a significant rise in the number of problems across various areas.
The increase in problems is affecting the overall efficiency and productivity.
Identifying the root causes of the problems is crucial to finding effective solutions.
Implementing proactive measures can help mitigate the impact of the increased problems.
Regular monitoring and analysis of the problem trends ca...read more
Q23. Tell me about shilpa Medicare limited?
Q24. What do you know about pharma products
Pharma products refer to medications and drugs used for the prevention, treatment, and management of various diseases and medical conditions.
Pharma products are developed through extensive research and clinical trials.
They are regulated by government agencies such as the FDA.
Pharma products can be prescription or over-the-counter (OTC) medications.
Examples of pharma products include antibiotics, pain relievers, and vaccines.
Pharma products can have side effects and interactio...read more
Q25. What is API?
API stands for Application Programming Interface. It is a set of protocols, routines, and tools for building software applications.
API allows different software applications to communicate with each other
It defines how software components should interact
APIs can be public or private
Examples of APIs include Google Maps API, Twitter API, and Facebook API
Q26. What is process validation ??
Process validation is the documented evidence that a process is capable of consistently producing a product that meets its predetermined specifications and quality attributes.
Process validation is a critical part of quality assurance in manufacturing.
It involves testing and verifying that a process consistently produces a product that meets its specifications.
Process validation typically involves three stages: process design, process qualification, and continued process verif...read more
Q27. How many audits you faced
I have faced audits in my previous role as a Deputy Manager.
I have faced audits from both internal and external auditors.
I have experience in preparing for audits, gathering necessary documentation, and participating in audit meetings.
I have successfully addressed audit findings and implemented corrective actions to improve processes.
I have been involved in audits related to financial records, compliance with regulations, and operational procedures.
Q28. What recent audit observations
I recently observed discrepancies in inventory management during an audit.
Identified inconsistencies in inventory records vs physical count
Noted lack of proper documentation for inventory transactions
Discovered expired or damaged inventory items not properly accounted for
Q29. Tell me Qms
Q30. How to improve Quality
Improving quality involves setting clear standards, continuous monitoring, feedback mechanisms, and employee training.
Establish clear quality standards and guidelines
Implement regular quality checks and audits
Collect feedback from customers and employees
Provide training and development opportunities for staff
Use quality improvement tools like Six Sigma or Lean methodologies
Q31. How to follow guidelines
Following guidelines involves understanding, implementing, and adhering to established rules and procedures.
Read and familiarize yourself with the guidelines thoroughly
Ask for clarification if any part of the guidelines is unclear
Implement the guidelines in your work or tasks
Regularly review and update your knowledge of the guidelines
Seek feedback on your adherence to the guidelines
Q32. What is an economics??
Q33. What are basic GMP Principles
GMP principles are guidelines for ensuring quality and safety in the manufacturing process.
GMP stands for Good Manufacturing Practices
GMP principles include maintaining a clean and hygienic manufacturing environment, proper documentation and record-keeping, and ensuring the quality of raw materials and finished products
Examples of GMP principles in action include regular equipment maintenance, employee training on proper manufacturing procedures, and thorough testing of produ...read more
Q34. Area classification under rlaf
Area classification under rlaf refers to the categorization of different areas within a warehouse based on their risk level and fire protection requirements.
Areas are classified as high, medium, or low risk based on factors such as the type of materials stored, presence of flammable substances, and proximity to ignition sources.
High-risk areas may include storage areas for flammable liquids or gases, while low-risk areas may include office spaces or break rooms.
Each classific...read more
Q35. What is 21cfr and following
21 CFR refers to the Code of Federal Regulations Title 21, which contains regulations related to food and drugs in the United States.
21 CFR is a set of regulations established by the Food and Drug Administration (FDA) in the United States.
It covers regulations related to food, drugs, medical devices, cosmetics, and more.
Compliance with 21 CFR is mandatory for companies operating in the food and drug industries.
Examples of regulations under 21 CFR include Good Manufacturing Pr...read more
Q36. Experience in section
I have extensive experience in leading a section, managing tasks, and ensuring team success.
Led a team of 15 employees in a retail store section
Managed inventory, schedules, and customer service in the section
Implemented new strategies to increase section sales by 20%
Received Employee of the Month for exceptional leadership in the section
Q37. What is marketing?
Q38. what is educational background
I have a Bachelor's degree in Business Administration from XYZ University.
Bachelor's degree in Business Administration
XYZ University
Q39. Difference between DCS & PLC
DCS is used for continuous control of complex processes in industries, while PLC is used for discrete control of machinery and equipment.
DCS is typically used in industries such as oil and gas, power plants, and chemical plants for continuous control of processes.
PLC is commonly used in manufacturing industries for discrete control of machinery and equipment.
DCS allows for centralized control of multiple control loops, while PLC is more decentralized and used for specific tas...read more
Q40. ok with 20% hike
Yes, I am okay with a 20% hike.
I am happy with the offer and appreciate the increase in salary.
I believe my skills and experience justify the hike.
I am excited to continue contributing to the company's success.
I am open to discussing any additional benefits or opportunities.
Q41. Calibration of instruments
Calibration of instruments is the process of adjusting and verifying the accuracy of measuring equipment.
Calibration ensures that instruments provide accurate and reliable measurements.
It involves comparing the readings of the instrument to a known standard.
Calibration should be done regularly to maintain accuracy.
Examples of instruments that require calibration include thermometers, pressure gauges, and scales.
Q42. Describe warehouse role
Warehouse role involves managing inventory, receiving and dispatching goods, and ensuring efficient storage and retrieval.
Managing inventory levels and ensuring stock availability
Receiving and dispatching goods accurately and efficiently
Organizing and maintaining the warehouse space
Ensuring compliance with safety and security regulations
Collaborating with other departments to optimize supply chain processes
Q43. Cleaning type of area
Maintaining cleanliness in all areas of the warehouse is essential for safety and efficiency.
Regularly sweep and mop floors to remove debris and spills
Empty trash bins and recycling containers daily
Clean and sanitize restrooms and break areas regularly
Organize and declutter storage shelves and racks
Implement a schedule for deep cleaning tasks such as dusting and window washing
Q44. HVAC description
HVAC stands for Heating, Ventilation, and Air Conditioning.
HVAC systems control temperature, humidity, and air quality in buildings.
Heating is typically provided by furnaces or boilers.
Ventilation involves exchanging indoor and outdoor air to maintain air quality.
Air conditioning cools and dehumidifies indoor air.
HVAC systems can include components such as ductwork, thermostats, and filters.
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