MSD Pharmaceuticals QA Executive Interview Questions and Answers

My favorite chemistry reaction is the Grignard reaction.

• Formation of a new carbon-carbon bond

• Involves the use of a Grignard reagent and an electrophile

• Commonly used in organic synthesis

• Example: Formation of a tertiary alcohol from a ketone

I have extensive technical knowledge in Quality Management Systems (QMS) and Good Manufacturing Practices (GMP).

• Certified in ISO 9001 and other relevant quality management standards

• Experience in implementing and maintaining QMS in previous roles

• Knowledge of FDA regulations and GMP guidelines

• Skilled in conducting internal audits and ensuring compliance with quality standards

• Continuous improvement mindset to enhance qual

I have extensive technical knowledge of the guidelines and processes performed on the shop floor.

• Proficient in understanding and implementing quality control measures

• Familiar with lean manufacturing principles and continuous improvement techniques

• Skilled in using various tools and equipment on the shop floor

• Knowledgeable about safety protocols and regulations in a manufacturing environment

Different types of qualification and its flow

• There are various types of qualifications such as academic, professional, vocational, and personal

• Academic qualifications include degrees, diplomas, and certificates earned from educational institutions

• Professional qualifications are awarded by professional bodies and demonstrate expertise in a specific field

• Vocational qualifications are job-specific and demonstrate practica...read more

Process validation is the documented evidence that a process is consistently producing a product that meets predetermined specifications and quality attributes.

• Process validation is a critical component of quality assurance in manufacturing.

• It involves establishing documented evidence that a process is capable of consistently producing a product that meets predetermined specifications and quality attributes.

• Process val...read more

Guidelines for process validation include establishing process parameters, conducting process performance qualification, and ongoing monitoring.

• Establish process parameters

• Conduct process performance qualification

• Ongoing monitoring

• Document all validation activities

• Ensure compliance with regulatory requirements

• Consider risk management principles

• Involve relevant stakeholders

Area qualifications refer to the specific skills and knowledge required for a particular job or industry.

• Area qualifications are often listed in job postings and include both technical and soft skills.

• Examples of area qualifications for a software developer may include proficiency in programming languages, knowledge of software development methodologies, and strong problem-solving skills.

• Area qualifications may also in...read more