Amneal Pharmaceuticals Interview Questions, Process, and Tips

Q1. Which guidelines do you read
Ans. 
I read industry-specific guidelines, company policies, and management best practices.
• Industry-specific guidelines such as ISO standards or regulatory requirements

• Company policies and procedures for consistency and compliance

• Management best practices for effective leadership and team development
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Q1. Last company worked for
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Q2. Last salary you received
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Q1. What is your education qualification?
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Q2. What projects have you worked on or would be working on?
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Q1. What was your past CTC?
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Q2. What are your expectations from our company?
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My role in army

Q1. 1. What is Process Validation Ans. Process validation is a established document of evidenced which provides the high degree of assurance that a specific process will consistently produce a product meeting...read more
Ans. 
Process validation is a documented evidence that ensures consistent production of products meeting predetermined specifications.
• Process validation provides a high degree of assurance for consistent product quality.

• It involves establishing documented evidence that a specific process consistently produces products meeting predetermined specifications.

• There are different types of process validation, including process vali...read more
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Q2. Hold time study 1) Bulk Blend/uniformity Sample -15th day (+-) 2 day -30th day (+-) 2 day -60th day (+-) 2 day Test to be performed 1 Description 2 Assay 3 LOD 4 MLT 2) Compressed tablet -90th day (+-) 2 ...read more
Ans. Cleaning validation- Cleaning validation is documented evidance that an approved cleaning procedure will provide equipment which is suitable for processing medicinal product. Type of Contamination :- 1 chemical 2 Biological 3 Physical Sampling techniques:- - Surface swab sampling. Swab sampling for Chemical analysis Sampling area is 5x5 Horizontal strokes and vertical strokes Swab sampling for Microbial analys...read more
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Q3. Qualifications:- Established document evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting it is pre determined specifications and quality ...read more
Ans. Temperature mapping:- Temperature mapping is a study in which it is ensured that environment condition of studies area is uniform and well within the acceptance criteria.
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Q4. Process validation protocol contents :- - Product details - Protocol approval sheet - Contents of process validation protocol. - Introduction - Objective - Scope -Responsibilities - Number of process va...read more
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