Micro Labs Quality Assurance Officer Interview Questions and Answers

Q1. What your daliy activitys IPQA
Ans. 
My daily activities as an In-Process Quality Assurance (IPQA) officer involve monitoring and ensuring quality standards are met during production.
• Conducting in-process inspections to verify product quality

• Reviewing production documentation for accuracy and compliance

• Identifying and addressing any quality issues or deviations

• Collaborating with production team to implement corrective actions

• Maintaining records of inspect
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Q2. What expect salary
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Q1. Job responsibilities
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Q2. Quality assurance questions
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Q1. Tell me about change Control? And give me One Example?
Ans. 
Change control is a process used to manage and document changes to a system or process.
• Change control ensures that changes are properly reviewed, approved, and implemented.

• It helps to minimize risks and ensure that changes do not negatively impact the quality or functionality of the system.

• Change control typically involves documenting the change request, assessing its impact, obtaining necessary approvals, implementing...read more
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Q2. What are the ypes of Process validation?
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Process validation is the process of establishing documented evidence that a process consistently produces a product meeting predetermined specifications.
• There are three types of process validation: prospective validation, concurrent validation, and retrospective validation.

• Prospective validation is conducted before the process is put into routine use.

• Concurrent validation is performed during routine production.

• Retrosp...read more
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Q3. How you are doing Audit trail?
Ans. 
Audit trail is maintained by documenting and tracking all activities and changes made to a system or process.
• Audit trail is created by recording all actions, events, and transactions that occur within a system.

• It helps in ensuring accountability, traceability, and compliance with regulations.

• Audit trail can be established through the use of logs, timestamps, and version control.

• It is important to capture relevant infor...read more
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Q4. Asking about APQR
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Q5. Are you interested in Microbiology analytical review?
Ans. 
Yes, I am interested in Microbiology analytical review.
• I have a strong background in microbiology and enjoy analyzing data in this field.

• I have experience conducting microbiological tests and interpreting the results.

• I am familiar with various microbiological techniques and methodologies.

• I am interested in staying updated with the latest advancements in microbiology research.

• I believe that my knowledge and skills in mi...read more
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Q1. Purified water specification?
Ans. 
Purified water specification refers to the set of requirements and standards that purified water must meet.
• Purified water should have a low level of impurities, such as minerals, chemicals, and microorganisms.

• It should meet the specifications outlined by regulatory bodies, such as the United States Pharmacopeia (USP) or European Pharmacopoeia (EP).

• The pH level of purified water should be within a specific range, typica...read more
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Q2. Purified water specification of Microbal
Ans. 
The purified water specification for microbial quality assurance.
• Microbial specification for purified water is crucial to ensure its safety and suitability for use.

• The specification typically includes limits for various microorganisms, such as bacteria, fungi, and endotoxins.

• Commonly used tests for microbial quality assessment include total viable count, microbial identification, and endotoxin testing.

• The specification...read more
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Q3. USP chapters of Microbial tesing of API and water
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Q4. Growth Pramotion tests
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Q5. Horizontal Autoclave validation
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Q6. Types of validation
Ans. 
Validation is the process of evaluating a system or component during or at the end of the development process to determine whether it satisfies specified requirements.
• Functional Validation: Ensuring that the system meets the functional requirements.

• Performance Validation: Verifying that the system performs as expected under different load conditions.

• Security Validation: Checking the system for vulnerabilities and ensur...read more
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Q1. Tell me about your self
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Q2. Are you willing to shift Vizag
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Q3. Salary discussion
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Q1. Discuss about your project?
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Q1. Discuss about subject related like disease and drugs
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Q2. Discuss about Quality management system and Data integrity
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Q1. What is the role of IPQA.
Ans. 
IPQA stands for In-Process Quality Assurance. It involves monitoring and inspecting the quality of products during the manufacturing process.
• IPQA ensures that products meet quality standards at every stage of production

• It involves conducting inspections, tests, and audits to identify and address any quality issues

• IPQA helps in preventing defects and ensuring compliance with regulations and standards

• Examples include che...read more
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Q2. What is the ECR/BPR/BCR.
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ECR/BPR/BCR stands for Engineering Change Request/Business Process Reengineering/Business Case Reengineering.
• ECR (Engineering Change Request) is a formal proposal to make a change to a product's design or manufacturing process.

• BPR (Business Process Reengineering) is the analysis and redesign of workflows within and between enterprises to optimize end-to-end processes and eliminate non-value-added tasks.

• BCR (Business Ca...read more
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Q3. How to perform area clearance or equipment clearance.
Ans. 
Area or equipment clearance involves thorough cleaning and inspection to ensure safety and quality standards are met.
• Start by removing all items from the area or equipment being cleared.

• Clean the area or equipment using appropriate cleaning agents and tools.

• Inspect the area or equipment for any damage, wear and tear, or contamination.

• Document the clearance process and any findings for record-keeping purposes.

• Ensure pro...read more
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Q4. Review point of BPR/BCR/ECR
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BPR/BCR/ECR are review points in business process management.
• BPR stands for Business Process Reengineering, involves radical redesign of processes for improvement.

• BCR stands for Business Continuity Review, ensures processes are in place to maintain operations during disruptions.

• ECR stands for Engineering Change Review, evaluates proposed changes to products or processes for impact.

• Review points help ensure efficiency,
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Q1. Salary discussion and company policies
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Q1. Selection of die ,Aql,alc,ccp,cqa, stratified sampling,data integrity,GMP,GDP etc
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Q2. Stratified sampling
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Q1. Self introduction
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Q2. Personal profile previous experience etc
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Q1. Experience related, personal experience,
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Q2. Job role,teem leadership experience.
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Q1. Different between QA and QC
Ans. 
QA focuses on preventing defects in the process, while QC focuses on identifying defects in the product.
• QA is process oriented, focusing on preventing defects by establishing processes and standards.

• QC is product oriented, focusing on identifying defects through testing and inspection.

• QA involves activities like process audits, training, and documentation.

• QC involves activities like product testing, inspections, and sa...read more
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Q2. Types of defect
Ans. 
Types of defects include functional, performance, cosmetic, and compatibility issues.
• Functional defects affect the core functionality of the product or system.

• Performance defects impact the speed, response time, or resource usage.

• Cosmetic defects are related to the appearance or aesthetics of the product.

• Compatibility defects arise when the product does not work well with other systems or devices.
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Standard of coding and defect of coding