10+ Teva Pharmaceuticals 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 materials and components are available and properly label...read more

BUA samples are taken from the calcaneus bone using a specialized ultrasound device.

• BUA stands for Broadband Ultrasound Attenuation

• Samples are taken from the heel bone (calcaneus)

• A specialized ultrasound device is used to measure BUA

• The procedure is non-invasive and painless

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 population.

• This technique is useful when the population has distin...read more

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.

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

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 specifications.

• Cpk is calculated using the formula: Cpk = min(USL - me...read more

ALCOA++ is a set of guidelines for data integrity in pharmaceutical manufacturing.

• ALCOA stands for Attributable, Legible, Contemporaneous, Original, and Accurate

• The two plus signs indicate additional requirements for electronic records

• ALCOA++ is used to ensure data integrity and compliance with regulatory requirements

• Examples of ALCOA++ requirements include audit trails, data backups, and access controls

ALCOA principle is a set of guidelines for data integrity in pharmaceutical manufacturing.

• ALCOA stands for Attributable, Legible, Contemporaneous, Original, and Accurate.

• It is used to ensure the quality and reliability of data in pharmaceutical manufacturing.

• Attributable means that all data must be linked to the person who generated it.

• Legible means that all data must be clear and easy to read.

• Contemporaneous means that data must be recorded at the time of the activity.

• Origin...read more

To tackle complex situations, break it down into smaller parts, prioritize tasks, seek input from others, and stay calm under pressure.

• Break down the complex situation into smaller, more manageable parts

• Prioritize tasks based on importance and urgency

• Seek input and advice from colleagues or experts in the field

• Stay calm and focused under pressure to make rational decisions

• Create a plan of action and adjust as needed based on new information

• Communicate effectively with team me...read more

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 associated risks.

• For example, an AQL of 1.5 means that no mo...read more