Hetero Biopharma
10+ Interview Questions and Answers
Q1. Deferentiate column volume and bed hight accordingly protine binding and how column selected for protine separation.
Column volume and bed height affect protein binding differently. Column selection for protein separation depends on various factors.
Column volume refers to the total volume of the column, while bed height is the height of the resin bed inside the column.
Protein binding is influenced by the surface area available for binding in the column, which is directly related to bed height.
A larger column volume allows for more protein binding capacity, while a taller bed height increase...read more
Q2. Y u choose this organization nd biopharma. Experience, stability
I chose this organization and biopharma due to their strong experience, stability, and alignment with my career goals.
I chose this organization because of their extensive experience in the biopharma industry.
The organization has a proven track record of stability and success.
I believe that working in the biopharma field will allow me to make a meaningful impact on patients' lives.
The organization's mission and values align with my own career goals and aspirations.
I am impress...read more
Q3. Change controls or deviations investigation procedures and it's risk assessment with escalations
Change controls and deviations investigation procedures involve risk assessment and escalations.
Establish clear change control procedures to document and track any changes made to processes or systems.
Implement a deviations investigation procedure to identify, assess, and address any deviations from standard practices.
Conduct risk assessments to evaluate the potential impact of changes or deviations on operations and quality.
Escalate significant changes or deviations to highe...read more
Q4. What is Protein, types of amino acid and what are Aromatic amino acid
Proteins are macromolecules composed of amino acids. Aromatic amino acids are a type of amino acid with a specific chemical structure.
Proteins are essential for the structure, function, and regulation of the body's tissues and organs.
There are 20 different types of amino acids that make up proteins.
Amino acids are classified into three groups: essential, nonessential, and conditional.
Aromatic amino acids have a ring structure in their chemical composition.
The three aromatic a...read more
Q5. GxP issues and procedures to complie as per regulatory standards
GxP issues and procedures refer to Good Practice standards in regulated industries to ensure compliance with regulatory requirements.
GxP issues include Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and Good Clinical Practice (GCP).
Procedures must be documented, followed consistently, and regularly reviewed for compliance.
Regular training and audits are essential to ensure adherence to GxP standards.
Examples of GxP procedures include maintaining accurate r...read more
Q6. Which type of water is produced the mcdp?
The type of water produced by the MCDP is potable water.
Potable water is safe for drinking and cooking.
It meets the standards set by regulatory agencies for human consumption.
Examples of sources of potable water include treated tap water and bottled water.
Q7. Define DNA ,RNA , Molarity,Normality and how to prepare 1molar solution.
DNA and RNA are genetic materials. Molarity and Normality are units of concentration. 1 molar solution is prepared by dissolving 1 mole of solute in 1 liter of solvent.
DNA and RNA are nucleic acids that carry genetic information
Molarity is the number of moles of solute per liter of solution
Normality is the number of equivalents of solute per liter of solution
To prepare 1 molar solution, dissolve 1 mole of solute in 1 liter of solvent
For example, to prepare 1 molar solution of...read more
Q8. Neutralization and it's important s
Neutralization is a chemical reaction between an acid and a base to form a neutral solution.
Neutralization involves the combination of H+ ions from an acid and OH- ions from a base to form water and a salt.
It is important in various industries such as pharmaceuticals, food and beverage, and wastewater treatment.
Neutralization helps in controlling pH levels, preventing corrosion, and ensuring product quality.
Example: Mixing hydrochloric acid (HCl) with sodium hydroxide (NaOH) ...read more
Q9. Global regulatory aspect
Global regulatory aspect refers to the laws and regulations that govern businesses on an international scale.
Understanding and complying with regulations in different countries
Adapting to changes in regulations across borders
Ensuring products or services meet global standards
Navigating trade agreements and tariffs
Managing risks associated with regulatory differences
Q10. Resin binding capacity
Resin binding capacity refers to the maximum amount of resin that can be bound to a substrate.
Resin binding capacity is influenced by factors such as surface area, porosity, and chemical composition of the substrate.
It is important to optimize resin binding capacity to ensure efficient production processes.
Examples of substrates with high resin binding capacity include activated carbon and ion exchange resins.
Q11. Good manufacturing practices
Good manufacturing practices are guidelines and procedures that ensure products are consistently produced and controlled according to quality standards.
Ensure cleanliness and hygiene in the production area
Follow standard operating procedures for all processes
Regularly calibrate and maintain equipment
Train staff on proper manufacturing practices
Document all production activities for traceability
Q12. How ro plant was running?
The plant was running smoothly and efficiently.
The plant was operating at full capacity
All equipment was functioning properly
Regular maintenance and checks were being conducted
Water quality was meeting all standards and regulations
Q13. What is wfi generation system?
WFI generation system stands for Water for Injection generation system, which is used in pharmaceutical industry to produce highly purified water for use in drug manufacturing.
WFI generation systems use various methods such as distillation, reverse osmosis, and ultrafiltration to remove impurities from water.
The purified water produced by WFI generation systems must meet strict quality standards set by regulatory agencies like the FDA.
WFI generation systems are essential in p...read more
Q14. What is ro plant?
RO plant stands for Reverse Osmosis plant, a water treatment system that removes impurities from water by using a partially permeable membrane.
RO plant uses reverse osmosis process to remove contaminants from water
It works by applying pressure to the water, forcing it through a semi-permeable membrane
The membrane allows only water molecules to pass through, leaving behind impurities
RO plants are commonly used for desalination, wastewater treatment, and producing drinking wate...read more
Q15. Column packing how to do
Column packing is a process of filling a chromatography column with a stationary phase.
Choose an appropriate stationary phase based on the separation requirements.
Prepare the column by cleaning and conditioning it.
Pack the column by carefully adding the stationary phase.
Ensure proper packing density and uniformity.
Test the packed column for efficiency and performance.
Q16. Column chromatography means
Column chromatography is a technique used to separate and purify components of a mixture based on their different affinities for a stationary phase and a mobile phase.
Column chromatography involves passing a mixture through a column packed with a stationary phase, such as silica gel or alumina.
The components of the mixture interact differently with the stationary phase, leading to their separation.
The mobile phase, typically a solvent, carries the components through the colum...read more
Q17. Explain Electrophoresis?
Electrophoresis is a technique used to separate and analyze molecules based on their size and charge.
A sample is placed on a gel and an electric field is applied.
Molecules move towards the opposite charge and are separated based on their size and charge.
Commonly used in DNA and protein analysis.
Can be used to diagnose genetic disorders and identify pathogens.
Different types include agarose gel electrophoresis and polyacrylamide gel electrophoresis.
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