PharmEng Technology
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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PharmEng Technology
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PharmEng Technology is a leading global provider of technical services and solutions to the pharmaceutical, biotechnology, and healthcare industries. With over 25 years of experience, we specialize in Commissioning, Qualification, and Validation (CQV) services for facilities, utilities, equipment, and processes. Our team of highly skilled professionals brings a wealth of industry expertise and knowledge to every project, ensuring that our clients receive the highest quality services and solutions. We pride ourselves on our ability to provide flexible, innovative, and cost-effective solutions that meet our clients' unique needs and challenges. At PharmEng Technology, we are committed to delivering excellence in everything we do. We work closely with our clients to understand their goals and objectives and develop customized solutions that deliver measurable results. Our focus on quality, safety, and compliance ensures that our clients can trust us to meet their most critical needs. As a trusted partner to some of the world's largest pharmaceutical companies, we have a proven track record of success in delivering high-quality technical services and solutions that drive operational efficiency, reduce costs, and enhance overall performance. We are dedicated to helping our clients succeed in an ever-evolving and highly competitive industry. At PharmEng Technology, we are passionate about what we do, and we are committed to delivering excellence in everything we do. Specialties: PharmEng Technology specializes in the planning, design, construction, and validation of Health Care, Laboratory, API Pharmaceutical and Biotechnology facilities and equipment, including computer systems. We provide professional services that meet both regulatory and business demands, following current Good Manufacturing Practices (cGMP), Good Engineering Practices (GEP), and Good Laboratory Practices (GLP).