Merck, Internship cleaning validation

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As an intern, you will contribute to the cleaning validation strategy definition, execution and reporting for GMP (Good Manufacturing Practices) manufacturing equipment. The success of this study will ensure the absence of contamination of the New Biological Entities produced for clinical trials.
Define the strategy: you will begin by confirming the cleaning validation strategy in accordance with internal and external standards/guidelines as well as quality phase appropriateness. This involves understanding the requirements of such study and apply it to BDC (Biotech Development Center) GMP manufacturing suites.
Design protocols study: your task will include designing protocols that meet regulatory and operational requirements.
Execute validation study: participate in executing parts of the cleaning validation study, ensuring compliance with GMP.
Data Analysis and report writing: analyse the data collected during the study and derive conclusions that will contribute to the final report.
Collaborate in writing the report summarizing the methodology, results, and recommendations.

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