Centaur Pharmaceuticals QC Microbiologist Interview Questions, Process, and Tips

Validation ensures that the system meets the user's needs, while qualification ensures that the system is installed and operates correctly.

• Validation confirms that the system meets the user's requirements and expectations.

• Qualification ensures that the system is installed correctly and operates within predefined specifications.

• Validation is more focused on user needs and expectations, while qualification is more focuse...read more

GLP stands for Good Laboratory Practice, which ensures the reliability and integrity of data generated in a laboratory setting.

• GLP is a set of guidelines for conducting non-clinical safety studies on chemicals, pharmaceuticals, and other products.

• It includes requirements for the organization, personnel, facilities, equipment, and documentation of studies.

• Data integrity refers to the accuracy, completeness, and reliabil...read more

HPLC and GC are analytical techniques used in chemistry to separate and analyze compounds in a mixture.

• HPLC stands for High Performance Liquid Chromatography, which uses a liquid mobile phase to separate compounds based on their interactions with a stationary phase.

• GC stands for Gas Chromatography, which uses a gas mobile phase to separate compounds based on their volatility and interactions with a stationary phase.

• Bot...read more

UV, IR, KF, and polarimeter are analytical instruments used for different types of analysis based on principles of light absorption, emission, and rotation.

• UV (Ultraviolet) spectrophotometer measures the absorption of ultraviolet light by a sample to determine its concentration or purity.

• IR (Infrared) spectrophotometer measures the absorption of infrared light by a sample to identify functional groups in organic compou...read more

Calibration of analytical balance is essential for accurate measurements in analytical chemistry.

• Calibration involves comparing the readings of the balance to known weights.

• Regular calibration ensures accuracy and reliability of measurements.

• Adjustments may be needed if the balance readings deviate from the known weights.

• Calibration should be done using a proper calibration weight and following manufacturer's instructi...read more

PH range is 0-14. Calibration ensures accuracy by adjusting the PH meter to known standards.

• PH range is from 0 to 14, with 7 being neutral

• Acidic solutions have a PH below 7, while alkaline solutions have a PH above 7

• Calibration involves adjusting the PH meter using buffer solutions of known PH values

• Regular calibration ensures accurate PH measurements

These are technical terms related to UV calibration and water content analysis.

• UV calibration parameters refer to the settings used to calibrate a UV spectrophotometer for accurate measurements.

• ROI method stands for Region of Interest method, which is a technique used to analyze specific areas of an image or sample.

• Water content and LOD (Limit of Detection) difference are important factors to consider when analyzing th

Regulatory guidelines are essential for ensuring compliance with QMS standards.

• ISO 9001:2015 is the most widely recognized QMS standard

• FDA regulations apply to medical device manufacturers

• EU MDR 2017/745 is the new regulation for medical devices in the European Union

• Regulatory guidelines provide a framework for implementing and maintaining QMS

• Non-compliance with regulatory guidelines can result in fines, legal action,

Change controls are procedures used to manage changes to a system or process.

• Documenting the change request

• Assessing the impact of the change

• Obtaining approval for the change

• Implementing the change

• Testing the change

• Reviewing and closing the change request