LifeCell International Quality Assurance Interview Questions and Answers

Q1. Factor affecting the lyophilization
Ans. 
Factors affecting lyophilization
• Temperature: The temperature during the lyophilization process affects the rate of sublimation and drying.

• Pressure: The pressure inside the lyophilizer chamber affects the rate of sublimation and drying.

• Product formulation: The composition and concentration of the product being lyophilized can impact the process.

• Freezing method: The method used to freeze the product prior to lyophilizati...read more
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Q2. What is the meaning of Triple point
Ans. 
The triple point is the temperature and pressure at which all three phases of a substance (solid, liquid, and gas) coexist in equilibrium.
• The triple point is a unique combination of temperature and pressure for a substance.

• At the triple point, the solid, liquid, and gas phases of the substance can coexist in equilibrium.

• It is the point on a phase diagram where all three phases meet.

• The triple point is a fixed point use...read more
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Q3. Validation of lyophilizer
Ans. 
Validation of lyophilizer involves testing and documentation to ensure its performance and reliability.
• Validation of lyophilizer is necessary to ensure that it consistently produces high-quality freeze-dried products.

• The process involves testing various parameters such as temperature, pressure, and drying time to ensure they meet predetermined specifications.

• Documentation of the validation process is crucial for regula...read more
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Q4. How to maintain HSO in lyophilized product
Ans. 
Maintaining HSO in lyophilized product involves proper storage conditions and packaging.
• Store the lyophilized product in a cool and dry environment to prevent moisture absorption.

• Use appropriate packaging materials that provide a barrier against moisture and oxygen.

• Ensure the lyophilized product is sealed tightly to prevent any exposure to air.

• Consider using desiccants or moisture-absorbing packets in the packaging.

• Per...read more
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Q1. Trackwise related basic questions and work profile.
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Q1. Trackwise configuration questions and support, crystal reports, webservices
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FDA related, IV, OV, documents preparation, ppts related

Q1. Work location , work culture, timing, salary discussion
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Q1. Read the following.. 1. Alcoa+ 2. QMS
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Q2. 3. Audit trails 4. Deviation vs incident 5. OOS
Ans. 
Audit trails, deviations vs incidents, and OOS are important concepts in quality management.
• Audit trails are chronological records that provide documented evidence of activities performed in a system.

• Deviations are unplanned events that do not meet specifications, while incidents are unexpected events that may or may not impact product quality.

• OOS (Out of Specification) results occur when test results fall outside esta...read more
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Q1. QMS related questions
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Q2. Installation and qualification
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Q1. Work experience related questions
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Q2. At what capacity are you working
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Q3. Which is your current project
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Q1. Environment health and safety management
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Q2. Environment health and safety responsibility
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16 Year manager

Q1. Manager Environment and safety legal compliance
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Q2. Legally responsible
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For HIRA

Group discussion

Q1. About what you are mentioning in resume and based on your experience the questions will be there.be prepare your resume with what you have skills
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Q2. 1) Introduce yourself 2) Technical experience in working area 3)Best part in your working experience 4) What are your expectations 5)Finally how much percentage your requirement
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