Sanofi Quality Specialist Interview Questions and Answers

Line clearance check points ensure safety and quality in the production process.

• Verify that all equipment and materials from the previous batch have been removed.

• Ensure that the production area is clean and free from any contamination.

• Confirm that all required documents and records are in place and properly filled out.

• Check that the equipment is properly calibrated and functioning correctly.

• Inspect that the correct raw...read more

Challenges faced while using a compression machine

• Ensuring proper calibration of the machine

• Maintaining consistent pressure and temperature

• Preventing contamination of the sample

• Ensuring proper cleaning and maintenance of the machine

• Dealing with unexpected errors or malfunctions

An audit trail is a record of all the events that occur during a process or transaction.

• It provides a chronological sequence of events.

• It helps in identifying errors, fraud, or unauthorized access.

• It ensures accountability and transparency.

• Examples include electronic medical records, financial transactions, and software development.

• It is important for compliance with regulations and standards.

AQL stands for Acceptable Quality Level and is a statistical sampling method used to determine the quality of a product or batch.

• AQL is used to determine the maximum number of defective items in a batch that is considered acceptable.

• It involves randomly selecting a sample of items from the batch and inspecting them for defects.

• The AQL level is determined based on the level of quality required for the product and the as...read more

Cpk is a statistical measure used to determine the capability of a process to produce products within customer specifications.

• Cpk measures the distance between the process mean and the closest specification limit.

• A Cpk value of 1 indicates that the process is capable of producing products within specifications.

• A Cpk value of less than 1 indicates that the process is not capable of producing products within specificatio...read more

Stratified sampling is a sampling technique where the population is divided into homogeneous groups and a sample is taken from each group.

• Stratified sampling is used to ensure that the sample represents the characteristics of the population.

• First, the population is divided into mutually exclusive and exhaustive groups called strata.

• Then, a random sample is taken from each stratum based on its proportion to the populati...read more