Senior Quality Assurance Officer
10+ Senior Quality Assurance Officer Interview Questions and Answers
Q1. What are the IPQC test for tablets/Capsule? (Manufacturing and Packing)
IPQC tests for tablets/capsules in manufacturing and packing include appearance, weight variation, disintegration, dissolution, and content uniformity.
Appearance inspection for color, shape, and size
Weight variation testing to ensure consistency
Disintegration testing to check if the tablet/capsule breaks down properly
Dissolution testing to assess the release of the active ingredient
Content uniformity testing to verify uniform distribution of the active ingredient
Q2. What are CQA & CPP for tablets and Capsules?
CQA stands for Critical Quality Attributes and CPP stands for Critical Process Parameters for tablets and capsules.
CQA are the key physical, chemical, biological, or microbiological characteristics that must be within an appropriate limit, range, or distribution to ensure the desired product quality.
CPP are the key process parameters that should be controlled within a narrow range or set points to ensure the product meets the desired quality attributes.
Examples of CQA for tab...read more
Q3. Explain process validation types
Process validation types include prospective, retrospective, and concurrent validation.
Prospective validation involves establishing specifications and procedures before production.
Retrospective validation involves reviewing historical data to verify processes were consistently in control.
Concurrent validation involves monitoring and evaluating processes during production.
Examples: Prospective validation - setting up new equipment. Retrospective validation - reviewing past pro...read more
Q4. What is line clearance
Line clearance is the process of ensuring that a production line or area is free from any previous materials, tools, or equipment before starting a new process.
Line clearance involves visually inspecting the production area to ensure it is clean and free of any leftover materials.
It also involves verifying that all necessary tools and equipment are in place for the new process.
Line clearance helps prevent contamination and mix-ups during production.
Examples: cleaning a packag...read more
Q5. What is quality assurance
Quality assurance is the process of ensuring that products or services meet specified requirements and standards.
Quality assurance involves establishing processes to prevent defects in products or services
It focuses on continuous improvement and monitoring of processes
Quality assurance includes activities such as audits, inspections, and testing
Examples include software testing to ensure a program functions correctly and food safety checks to prevent contamination
Q6. What is change control
Change control is a process used to ensure that changes to a system are implemented in a controlled and systematic manner.
Change control involves documenting and tracking changes to a system or process.
It includes evaluating the impact of proposed changes and obtaining approval before implementation.
Change control helps prevent unauthorized changes and ensures that all changes are properly tested and validated.
Examples of change control include software updates, equipment upg...read more
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Q7. What is preventive maintenance
Preventive maintenance is proactive maintenance performed on equipment or systems to prevent breakdowns and ensure optimal performance.
Regularly scheduled inspections and servicing
Replacing worn out parts before they fail
Cleaning and lubricating machinery
Updating software to prevent bugs or security vulnerabilities
Q8. What is in process samples
In process samples are samples taken during the manufacturing process to monitor quality and ensure consistency.
In process samples are collected at various stages of production to check for quality and consistency.
These samples help identify any issues early on and prevent defects in the final product.
They are typically tested for parameters such as purity, potency, and contamination.
Examples include taking samples of a drug formulation during mixing or sampling a food produc...read more
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Q9. What is validation
Validation is the process of ensuring that a product, service, or system meets the requirements and specifications set forth for it.
Validation involves confirming that the product meets the customer's needs and expectations
It is a systematic and objective process of evaluating whether a product or service complies with the specified requirements
Validation is often done through testing, inspection, and review processes
Examples of validation include software testing to ensure i...read more
Q10. What is dispatch
Dispatch is the process of sending out goods or messages for delivery or transmission.
Dispatch involves organizing and sending out items or information to their intended recipients.
It is an important part of logistics and communication processes.
Examples include dispatching packages for delivery, dispatching emergency services to a location, or dispatching messages to team members.
Q11. What is sampling
Sampling is the process of selecting a subset of individuals or items from a larger population to make inferences about the whole.
Sampling involves selecting a representative sample from a larger population.
Different sampling methods include random sampling, stratified sampling, and convenience sampling.
Sampling helps in making predictions and generalizations about the population based on the sample.
Sampling is commonly used in quality assurance to test a subset of products o...read more
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