Pharmaceutical job Quality Assurance/Quality Control Manager Interview Questions and Answers

PCR stands for Polymerase Chain Reaction, a technique used in molecular biology to amplify a single or a few copies of a piece of DNA.

• PCR is a common technique used in molecular biology to make multiple copies of a specific DNA segment.

• It involves a series of temperature changes to denature, anneal, and extend DNA strands.

• PCR is used in various applications such as DNA sequencing, gene cloning, and genetic testing.

• Exam...read more

Buffer preparation involves mixing a weak acid and its conjugate base to maintain a stable pH.

• Dissolve the weak acid in water

• Add the conjugate base to the solution

• Adjust the pH as needed with a strong acid or base

• Use a pH meter to ensure the desired pH is achieved

• Common buffers include phosphate buffer, acetate buffer, and Tris buffer

To prepare Specifications and STP, review MFC and MPR, follow these steps.

• Gather requirements and define specifications for the product or process.

• Create detailed test cases in the Software Test Plan (STP) based on the specifications.

• Review the Master Formula Card (MFC) for manufacturing processes and procedures.

• Review the Master Production Record (MPR) for documenting the production process.

• Ensure that the specificati...read more

Test Input Document (TID) and Test Task Document (TTD) are documents used in Quality Assurance to outline testing requirements and tasks.

• TID (Test Input Document) outlines the testing requirements, including test scenarios, test cases, and expected results.

• TTD (Test Task Document) outlines the specific tasks to be performed during testing, including who will perform each task and when it will be completed.

Stability studies are conducted to evaluate the stability of a product over time under various conditions.

• Stability studies help determine the shelf life of a product.

• They assess how the quality of a product changes over time.

• Factors such as temperature, humidity, light exposure, and packaging are considered in stability studies.

• Results of stability studies are used to establish storage conditions and expiration dates ...read more

Reviews of PVR and PQRS can be conducted through a systematic process involving data analysis and evaluation.

• Collect and analyze data related to PVR and PQRS

• Evaluate the performance and quality based on established criteria

• Identify areas of improvement and develop action plans

• Implement changes and monitor the impact

• Continuously review and update the process to ensure ongoing quality assurance