10+ Senior Executive Quality Control Interview Questions and Answers

Computer systems used in the medical field must be compliant with 21 CFR part 11.

• Electronic medical record systems

• Laboratory information management systems

• Pharmacy management systems

• Clinical trial management systems

• Medical device software

• Electronic data capture systems

Both 21 CFR part 11 and EU Annex 11 are equally precise for computer system.

• Both regulations provide specific guidelines for electronic records and signatures.

• 21 CFR part 11 applies to FDA-regulated industries in the US, while EU Annex 11 applies to pharmaceutical companies operating in the EU.

• Both regulations require validation of computer systems and controls to ensure data integrity and security.

• EU Annex 11 places more emphasis on risk management and data privacy.

• Complianc...read more

Handling customers and internal communications in NC involves clear communication channels and timely responses.

• Establish clear communication channels for customers and internal teams

• Ensure timely responses to customer inquiries and feedback

• Implement regular updates and feedback mechanisms to keep stakeholders informed

• Train staff on effective communication strategies and customer service best practices

I handle quality deviation by identifying the root cause, implementing corrective actions, and monitoring the effectiveness of the solution.

• Investigate the deviation thoroughly to identify the root cause

• Implement corrective actions to prevent recurrence

• Communicate the deviation and corrective actions to relevant stakeholders

• Monitor the effectiveness of the solution to ensure sustained improvement

• Document the deviation and corrective actions taken for future reference

Understanding the role of LOQ and LOD in HPLC for related substances assay in UV testing.

• LOQ (Limit of Quantification) is the lowest concentration that can be reliably quantified.

• LOD (Limit of Detection) is the lowest concentration that can be reliably detected but not quantified.

• In HPLC, LOQ and LOD are critical for ensuring the accuracy of related substances assays.

• For example, if a drug has an LOD of 0.1 ppm, it means concentrations below this may not be detected.

• UV detect...read more

8D Analysis is a problem-solving methodology used to identify, correct, and prevent recurring problems.

• 8D stands for 8 disciplines, each representing a step in the problem-solving process.

• It involves identifying the problem, forming a team, implementing temporary and permanent corrective actions, and preventing recurrence.

• Examples of tools used in 8D Analysis include fishbone diagrams, Pareto charts, and root cause analysis.

Six Sigma is a data-driven methodology used to improve processes by reducing defects and variation.

• Six Sigma aims to achieve near perfection in processes by identifying and eliminating causes of defects.

• It uses statistical tools and techniques to measure and analyze process performance.

• Six Sigma projects follow a structured approach known as DMAIC (Define, Measure, Analyze, Improve, Control).

• Certification levels include Yellow Belt, Green Belt, Black Belt, and Master Black Be...read more

ICH guideline provides recommendations for conducting stability studies on pharmaceutical products.

• ICH stands for International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use

• The guideline outlines the minimum requirements for conducting stability studies on drug substances and drug products

• It includes recommendations on the design, testing conditions, and evaluation of stability data

• Stability studies are conducted to determine the shelf ...read more

HPLC principle stands for High Performance Liquid Chromatography, a technique used to separate, identify, and quantify components in a mixture.

• HPLC involves the use of a liquid mobile phase and a solid stationary phase to separate components based on their interactions with the phases.

• It is a widely used analytical technique in various industries such as pharmaceuticals, food and beverage, environmental analysis, and more.

• HPLC can be used to analyze complex mixtures, such as ...read more

GAMP categories classify software and systems in regulated industries for validation purposes.

• Category 1: Infrastructure Software - Examples include operating systems and database management systems.

• Category 2: Software with Fixed Functionality - Examples are commercial off-the-shelf (COTS) software like Microsoft Office.

• Category 3: Configurable Software - Examples include laboratory information management systems (LIMS) that can be configured for specific needs.

• Category 4: B...read more