Intern
5 days ago
Internship Scope:
Please describe briefly the main work area(s) which the student(s) will be involved in and the objective(s) or target(s) for student(s) to achieve.
1. Statistical analysis of product critical attributes as part of ongoing process verification and Process Performance Qualification for Product
2. Aseptic Vessel Integrity Requalification
3. Establishing filling and packaging line performance baseline
Prerequisites/Requirements
Basic Statistical knowledge of process capability index Interest to learn and inquisitive mind to the process and equipment Ability to fluently read, write, understand, and communicate in English Ability to learn fast and work independently Strong problem solving and communication skills
Skills developed through this internship:
Gain exposure to some of the systems and equipment used in the manufacturing process, understanding how they work, how they are maintained in a validated state control through hands-on experience with working on the requalification Gain a better understanding of the products that are manufactured on site through statistical analysis of the product performance for the products that were manufactured in the past 12 months and detecting for adverse trends, performing investigation of potential causes when adverse trends are detected. This is complemented with exposure to performance of process performance qualification of product from scale up batches which allows the student to be able exposure to stage 2 and 3 of product qualification process. In depth understanding of the continuous operation process (filling and packaging) and participating in the design and establishment of the critical process parameters to be monitored.
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