Senior Officer QA

Senior Officer QA Interview Questions and Answers

Updated 5 Aug 2024

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Q1. What is line clearance at different stages

Ans.

Line clearance at different stages refers to the process of ensuring that a production line or area is free from any previous product or material before starting a new production or process.

  • Line clearance is performed at various stages such as before starting a new batch, after completing a batch, or during equipment changeover.

  • It involves thorough cleaning, removal of any residual material, and verification of cleanliness.

  • Line clearance is important to prevent cross-contamin...read more

Q2. What is AQL sampling and limits

Ans.

AQL sampling is a statistical method used in quality control to determine the acceptable quality level of a product batch.

  • AQL stands for Acceptable Quality Level, which is the maximum percentage of defective units that is considered acceptable in a batch of products.

  • AQL sampling involves randomly selecting a sample of units from a batch and inspecting them for defects.

  • The AQL limits are predetermined values that specify the maximum number of defective units allowed in a sampl...read more

Q3. How does a microwave oven works.

Ans.

Microwave ovens use electromagnetic radiation to heat food by exciting water molecules within it.

  • Microwaves are a form of electromagnetic radiation with a wavelength ranging from 1 millimeter to 1 meter.

  • The microwaves penetrate the food and cause the water molecules to vibrate, generating heat through friction.

  • The rotating plate inside the microwave helps to ensure even heating of the food.

  • Metal objects should not be placed inside a microwave as they can cause sparks due to r...read more

Q4. How to perform sampling?

Ans.

Sampling is the process of selecting a subset of a population to represent the entire group for testing or analysis.

  • Determine the population to be sampled

  • Choose a sampling method (random, stratified, cluster, etc.)

  • Decide on the sample size

  • Collect the samples

  • Analyze the samples and draw conclusions

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Q5. What is mediafill interventions

Ans.

Mediafill interventions are activities conducted to assess the effectiveness of aseptic processes in pharmaceutical manufacturing.

  • Mediafill interventions involve simulating the manufacturing process using a sterile growth medium instead of the actual product.

  • These interventions are performed to evaluate the capability of personnel, equipment, and facilities to maintain sterility during production.

  • During mediafill interventions, samples are collected and tested for microbial c...read more

Q6. What Are Class A preserative.

Ans.

Class A preservatives are antimicrobial agents that are considered safe for use in food and pharmaceutical products.

  • Class A preservatives are substances that prevent the growth of microorganisms in products.

  • They are considered safe for consumption and are approved by regulatory authorities.

  • Examples of Class A preservatives include sodium benzoate, potassium sorbate, and parabens.

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Q7. What is deviation?

Ans.

Deviation is a departure from a standard or norm, often in the context of quality assurance.

  • Deviation is a variation from an established process or procedure.

  • It can be caused by human error, equipment malfunction, or external factors.

  • Deviation must be documented, investigated, and corrective actions taken to prevent recurrence.

  • Examples include a machine malfunction causing a product defect or a missed step in a manufacturing process.

Q8. What is media fill

Ans.

Media fill is a simulation test used in pharmaceutical manufacturing to ensure the aseptic filling process is performed correctly.

  • Media fill involves filling sterile growth media instead of actual product to simulate the manufacturing process.

  • The filled containers are then monitored for any microbial growth to ensure the process is aseptic.

  • Media fill tests are conducted periodically to validate the aseptic filling process and equipment.

  • Examples of media fill tests include fil...read more

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