30+ Senior Executive QA Interview Questions and Answers

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

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

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

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

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

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

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.

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

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

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

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

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

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

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

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

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.

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

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

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

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

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

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

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

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

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

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

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

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

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

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.

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.

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

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

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

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

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.