Senior Executive QA
30+ Senior Executive QA Interview Questions and Answers
Q1. WHAT IS THE DIFFERENT TYPES OF QUALIFICATION AND ITS FLOW?
Different types of qualification and its flow
There are various types of qualifications such as academic, professional, vocational, and personal
Academic qualifications include degrees, diplomas, and certificates earned from educational institutions
Professional qualifications are awarded by professional bodies and demonstrate expertise in a specific field
Vocational qualifications are job-specific and demonstrate practical skills and knowledge
Personal qualifications are self-tau...read more
Q2. What are the contents process validation protocol & report
The contents of a process validation protocol and report include detailed information about the validation process and its results.
Purpose and scope of the validation
Description of the process being validated
Validation criteria and acceptance criteria
Methods and procedures used for validation
Sampling plan and sample size
Data collection and analysis
Results and conclusions
Recommendations for process improvements
Signatures and approvals
Senior Executive QA Interview Questions and Answers for Freshers
Q3. What is reverse osmosis? Function of Activated carbon filter?
Reverse osmosis is a water purification process that removes ions, molecules, and larger particles from drinking water.
Reverse osmosis uses a semi-permeable membrane to filter out impurities from water.
It is commonly used in water treatment plants and home water filtration systems.
Activated carbon filter is used to remove organic compounds and chlorine from water.
It works by adsorbing impurities onto the surface of the carbon filter.
Activated carbon filter is often used in co...read more
Q4. What is peocedure of equipment cleaning and how nay type and how to calculate MACO?
Equipment cleaning procedure involves thorough cleaning and sanitization to prevent contamination. MACO is calculated based on the maximum allowable carryover of a product.
Equipment cleaning should follow a detailed procedure outlined in the standard operating procedures (SOPs)
Different types of cleaning agents may be used based on the equipment and the substances it comes in contact with
MACO calculation involves determining the maximum allowable carryover of a product on the...read more
Q5. What is Change Control procedur and how to evaluate?
Change control procedure is a process used to manage changes to a system or product in a controlled and systematic manner.
Establish a change control board or committee to review and approve changes.
Document all proposed changes including the reason for the change, impact analysis, and proposed implementation plan.
Evaluate changes based on criteria such as impact on quality, cost, schedule, and risk.
Implement changes only after approval from the change control board.
Monitor an...read more
Q6. What is data integrity and same as explain to ALCOA+?
Data integrity refers to the accuracy, consistency, and reliability of data throughout its lifecycle. ALCOA+ stands for Attributable, Legible, Contemporaneous, Original, Accurate, and Complete.
Data integrity ensures that data is accurate, consistent, and reliable from creation to deletion.
ALCOA+ principles emphasize that data should be attributable to its source, legible, contemporaneous, original, accurate, and complete.
For example, in a pharmaceutical company, maintaining d...read more
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Q7. What is Your Current CTC and in-hand salry ?
I am currently earning a competitive salary based on my experience and qualifications.
My current CTC is in line with industry standards for a Senior Executive QA role.
I receive a competitive in-hand salary that reflects my skills and expertise.
I am open to discussing compensation further during the interview process.
Q8. Modification & improvement of instruments based on requirement of fertilizer
Modification & improvement of instruments for fertilizer requirements
Identify the specific requirements of the fertilizer
Analyze the current instruments and their limitations
Develop modifications or new instruments to meet the requirements
Test and validate the effectiveness of the modified/improved instruments
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Q9. How to prepare 0.02 N HCL from concentrated HCL
To prepare 0.02 N HCL from concentrated HCL, dilute 2.8 mL of concentrated HCL to 1 liter with distilled water.
Measure 2.8 mL of concentrated HCL using a pipette.
Add the concentrated HCL to a volumetric flask containing about 800 mL of distilled water.
Swirl the flask to mix the contents.
Add more distilled water to the flask until the volume reaches 1 liter.
Swirl the flask again to ensure uniform mixing of the solution.
The resulting solution will be 0.02 N HCL.
Q10. Tell me about change control
Change control is a process that ensures all changes to a system are documented, reviewed, approved, and implemented in a controlled manner.
Change control is essential for maintaining the stability and integrity of a system.
It involves documenting and tracking all proposed changes, including their impact and risks.
Changes are reviewed and approved by a designated change control board or committee.
Proper testing and validation are conducted before implementing changes to minim...read more
Q11. 3. Define deviation. unplanned & planned deviation with example.
Deviation is a departure from approved procedures or specifications. It can be planned or unplanned.
Planned deviation is a pre-approved change in a process or procedure. For example, changing the manufacturing process of a drug to improve its quality.
Unplanned deviation is an unexpected event that occurs during the manufacturing process. For example, a machine breakdown that causes a delay in production.
Both types of deviation must be documented and investigated to determine ...read more
Q12. guidelines for QMS, Change control, Stability, Artwork etc.
Guidelines for QMS, change control, stability, artwork etc.
QMS guidelines should cover all aspects of quality management, including documentation, training, and audits.
Change control guidelines should outline the process for making changes to products or processes, including documentation and approval requirements.
Stability guidelines should cover the testing and monitoring of product stability over time, including storage conditions and testing intervals.
Artwork guidelines s...read more
Q13. During filtration filter shock happened means wt we have to do?
Filter shock during filtration can be caused by sudden changes in pressure or flow rate, leading to filter damage or failure.
Immediately stop the filtration process to prevent further damage to the filter
Inspect the filter for any signs of damage or clogging
Replace the filter if necessary
Investigate the root cause of the filter shock to prevent future occurrences
Q14. What is validation? And about FSMS
Validation is the process of ensuring that a product meets the specified requirements and standards. FSMS is a Food Safety Management System.
Validation ensures that a product meets the specified requirements and standards
It involves testing and verifying the product's functionality
FSMS is a system that ensures food safety throughout the supply chain
It includes hazard analysis, risk assessment, and control measures
FSMS is based on international standards such as ISO 22000
Q15. 4. How to check Artwork . Steps. Rules.
Artwork should be checked for accuracy and compliance with regulations.
Verify all text is accurate and matches the approved copy
Ensure all required elements are present and in the correct location
Check for proper color usage and consistency
Confirm compliance with regulatory requirements
Perform a final proofread for any errors or inconsistencies
Q16. 1.Why preparation in APQR in products. 2. OOS investigation 3. Plant round activity
Preparation in APQR is essential for evaluating product quality, OOS investigations are crucial for identifying and resolving deviations, and plant round activities ensure compliance and efficiency.
APQR (Annual Product Quality Review) is prepared to evaluate the quality of products over a period of time, identify trends, and ensure continuous improvement.
OOS (Out of Specification) investigations are conducted to identify the root cause of deviations in product quality, take c...read more
Q17. Difference between incident and deviation
Incident is an unexpected event that may or may not have an impact on product quality, while deviation is a planned or intentional change that may affect product quality.
Incident is unplanned, while deviation is planned
Incident may or may not have an impact on product quality, while deviation may affect product quality
Incident requires investigation to determine the root cause, while deviation requires investigation to determine the impact on product quality
Examples of incide...read more
Q18. How many test parameters. Calculation for assay test. Alcoa plus
The number of test parameters for assay test using Alcoa plus is dependent on the specific requirements of the test.
The number of test parameters will vary depending on the specific assay test being performed.
Alcoa plus is a data integrity framework used in the pharmaceutical industry.
The calculation for assay test parameters may include factors such as sample size, concentration, and purity.
It is important to carefully define and document all test parameters to ensure accura...read more
Q19. At what range UV does work?
UV works in the range of 100-400 nm.
UV radiation is classified into three types: UVA (315-400 nm), UVB (280-315 nm), and UVC (100-280 nm).
UV radiation is used for various purposes such as sterilization, curing, and tanning.
UV radiation can be harmful to human skin and eyes, causing sunburn, skin aging, and even skin cancer.
Q20. Aseptic media fill validation and its importance fda guidelines
Aseptic media fill validation is a critical process to ensure the sterility of pharmaceutical products.
Aseptic media fill validation is a process of simulating the manufacturing process to ensure that the aseptic technique is maintained throughout the process.
It is important to comply with FDA guidelines to ensure the safety and efficacy of pharmaceutical products.
The FDA requires aseptic media fill validation to be performed annually and after any significant changes to the ...read more
Q21. What is GLP? And GMP, Ccp
GLP stands for Good Laboratory Practice, GMP stands for Good Manufacturing Practice, and CCP stands for Critical Control Point.
GLP is a set of guidelines for conducting non-clinical laboratory studies that ensure the quality and integrity of data.
GMP is a set of guidelines for ensuring that pharmaceutical products are consistently produced and controlled according to quality standards.
CCP is a step in the production process where control can be applied to prevent, eliminate, ...read more
Q22. What is Risk management
Risk management is the process of identifying, assessing, and prioritizing potential risks and taking measures to minimize or mitigate their impact.
Identifying potential risks
Assessing the likelihood and impact of each risk
Prioritizing risks based on their severity
Developing strategies to minimize or mitigate risks
Implementing risk management plans
Monitoring and reviewing risks regularly
Examples: financial risk, cybersecurity risk, project risk
Q23. Enlist Parameters of Compressed air validation?
Parameters of compressed air validation include purity, pressure, dew point, particle count, and microbial content.
Purity: Ensure absence of contaminants such as oil, water, and particles.
Pressure: Confirm air pressure meets specified requirements.
Dew Point: Measure moisture content to prevent corrosion and freezing.
Particle Count: Verify air cleanliness by counting particles of various sizes.
Microbial Content: Test for presence of bacteria and other microorganisms.
Examples: ...read more
Q24. 2. Define Life Cycle of change control.
The life cycle of change control involves planning, implementing, reviewing, and approving changes to a system or process.
Planning: Identify the need for change and create a plan.
Implementation: Make the necessary changes and document them.
Review: Evaluate the effectiveness of the changes and identify any issues.
Approval: Obtain approval from stakeholders before implementing the changes.
Examples: Updating software, changing manufacturing processes, revising policies and proce...read more
Q25. What is VMP
VMP stands for Vendor Master Plan. It is a strategic document that outlines the approach and activities for managing vendors in an organization.
VMP is a comprehensive plan that includes vendor selection, evaluation, and performance management.
It defines the criteria for selecting vendors and the process for evaluating their performance.
The plan also outlines the responsibilities and roles of various stakeholders involved in vendor management.
VMP helps in ensuring that vendors...read more
Q26. Trouble shooting and different types of volumns
Troubleshooting involves identifying and resolving issues, while different types of volumes refer to varying levels or quantities.
Troubleshooting involves identifying and resolving problems or issues that arise in a system or process.
Different types of volumes can refer to varying levels or quantities of data, such as low volume, high volume, or peak volume.
Troubleshooting different types of volumes requires understanding the specific challenges and potential bottlenecks asso...read more
Q27. What is expected CTC.
Expected CTC should be based on industry standards, experience, skills, and job responsibilities.
Expected CTC should be in line with industry standards for the role and level of experience.
Consider the candidate's skills, qualifications, and past work experience when determining the expected CTC.
Job responsibilities and the scope of the role should also be taken into account when discussing expected CTC.
It is important to negotiate and discuss the expected CTC openly and tran...read more
Q28. Explain equipment qualification process?
Equipment qualification process ensures that equipment is suitable for its intended use by following a systematic approach.
Define equipment requirements and specifications
Select appropriate equipment based on requirements
Install and set up equipment according to manufacturer's guidelines
Perform operational and performance qualification tests
Document all qualification activities and results
Q29. What is cleaning validation?
Cleaning validation is the process of ensuring that cleaning procedures effectively remove residues from equipment used in manufacturing processes.
Cleaning validation is essential in industries such as pharmaceuticals, food and beverage, and medical devices to prevent cross-contamination and ensure product quality.
It involves establishing documented evidence that cleaning procedures consistently and effectively remove residues to predetermined levels of cleanliness.
Validation...read more
Q30. Why Internal audit required
Internal audit is required to ensure compliance with regulations, identify risks, improve processes, and enhance overall quality.
Ensures compliance with regulations and standards
Identifies risks and weaknesses in processes
Improves processes and procedures
Enhances overall quality and efficiency
Provides assurance to stakeholders
Q31. What is ALCOA principle
ALCOA principle is a guideline for ensuring data integrity in regulated industries, emphasizing data should be attributable, legible, contemporaneous, original, and accurate.
Attributable - Data should be traceable to its source.
Legible - Data should be clear and easy to read.
Contemporaneous - Data should be recorded at the time of observation.
Original - Data should be the first recording of the information.
Accurate - Data should be error-free and true to the actual observatio...read more
Q32. Any idea of OSD knowledge
OSD stands for Oral Solid Dosage. It refers to the form of medication that is taken orally in a solid form such as tablets or capsules.
OSD is a common form of medication that is taken orally in a solid form
Examples of OSD include tablets, capsules, and powders
OSD is often used to treat a variety of medical conditions
Quality assurance is important in the manufacturing of OSD to ensure safety and efficacy
Q33. Current CTC Expected CTC
Answered the question about current and expected CTC.
Shared the current CTC and expected CTC.
Explained the reason for expecting the new CTC.
Mentioned any additional benefits or perks expected.
Discussed the possibility of negotiation.
Maintained a professional and polite tone throughout the conversation.
Q34. 1.Define QMS In Pharma.
QMS in Pharma refers to the set of policies, procedures, and processes that ensure the quality of pharmaceutical products.
QMS includes quality control, quality assurance, and quality improvement.
It ensures compliance with regulatory requirements and industry standards.
QMS involves documentation, training, and continuous monitoring.
Examples of QMS tools include SOPs, CAPAs, and audits.
QMS is essential for ensuring patient safety and product efficacy.
Q35. What is gmp in pharma
GMP in pharma stands for Good Manufacturing Practice, which are guidelines and regulations ensuring the quality and safety of pharmaceutical products.
GMP regulations are enforced by regulatory agencies to ensure pharmaceutical products are consistently produced and controlled according to quality standards.
These standards cover all aspects of production, including the facilities, equipment, personnel, and processes.
Examples of GMP requirements include proper documentation, va...read more
Q36. What is POLL TAX?
A poll tax is a tax levied on individuals rather than on income or property.
A poll tax is a fixed tax amount that every individual must pay, regardless of their income or property.
Historically, poll taxes have been used as a way to disenfranchise certain groups of people by making it difficult for them to afford to vote.
One famous example of a poll tax is the tax imposed on African Americans in the southern United States during the Jim Crow era.
Poll taxes have been abolished ...read more
Q37. Explain your M Pharm project.
My M Pharm project was on the development of a sustained release formulation of an anti-diabetic drug.
The project involved the use of various polymers to achieve sustained release of the drug.
I conducted in vitro and in vivo studies to evaluate the efficacy of the formulation.
The results showed that the sustained release formulation had better glucose-lowering effects compared to the immediate release formulation.
I also optimized the formulation to achieve the desired release...read more
Q38. Reduce the leaves
Reduce the number of employees taking leaves
Implement a more efficient leave management system
Encourage employees to plan their leaves in advance
Offer incentives for employees with good attendance records
Provide options for remote work to reduce the need for leaves
Q39. Type of Validation
Validation is the process of evaluating software to ensure it meets requirements and specifications.
Validation confirms that the product meets the user's needs and requirements.
It is typically done after verification to ensure the software is fit for purpose.
Examples include user acceptance testing, system testing, and functional testing.
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