Shaiful Zaini is an experienced Validation Specialist currently employed at PharmEng Technology Asia since October 2015. Key responsibilities include qualification of refrigeration systems, shelf life studies, and process re-evaluation to ensure compliance with cGMP and GEP standards, specifically in regulatory contexts like TGA, TuV, and FDA. Prior roles involved assessing systems such as reverse osmosis and sterilization, developing documentation and protocols, and ensuring adherence to 21 CFR Part 11. Shaiful holds a Master of Science in Biotechnology and a Bachelor of Science in Industrial Biology from Universiti Teknologi Malaysia.
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