Tan Wei Run Email and Phone Number

As the Quality Lead for our Pilot Vaccine Plant, I play role in maintaining and enhancing the quality of our vaccine manufacturing processes. I am responsible for overseeing the quality control and assurance functions, implementing quality standards and regulations, continuous improvement initiatives. My expertise and leadership are essential in ensuring the safety and efficacy of our vaccine products. Responsibilities:Quality Control and Assurance:Develop, implement, and manage quality control procedures and systems to ensure compliance with regulatory requirementsConduct thorough inspections and audits of manufacturing processes and facilities to identify and rectify quality issues.Collaborate with cross-functional teams to establish quality objectives and Key Performance Indicators.Regulatory Compliance:Stay up-to-date with all relevant regulatory guidelines, including NPRA and WHO standards, and ensure compliance with these regulations.Quality Documentation:Maintain accurate and comprehensive documentation of quality processes, including batch records, SOPs, and validation protocols.Ensure all documentation is in accordance with cGMP (current Good Manufacturing Practices) standards.Quality Training:Train and develop personnel to enhance their skills and knowledge.Organize training programs for employees.Continuous Improvement:Identify opportunities for process improvements and lead quality-related initiatives to enhance efficiency and product quality.Conduct root cause analysis and implement corrective and preventive actions (CAPAs)Supplier Quality Management:Collaborate with suppliers and vendors to ensure the quality of incoming materials and components.Establish and maintain supplier quality agreements and performance metrics.Quality Audits and Inspections:Coordinate and participate in internal and external quality audits and inspections.Work closely with regulatory agencies during inspections and respond to findings appropriately.

- Planing and execution of experiment- Liase with Senior Scientific Executive to prepare and compile presentation slides for presentation to the Chief Scientific Officer and Management Board- Aid Assistant Laboratory Manager with reporting and maintaining of lab equipment- Conduct Experiments related to gene insertion, knocking out genes and expression in E.coli,- Isolation of microbes from environmental sample for preliminary enzymatic screening- Running of small scale Bioreactors 3L and 5L fo- Good indepth knowledge of Good Laboratory Practice,Handling and Disposing of hazardous chemical waste.- Knowledge of using Microsoft Excel,Word and Powerpoint

During the duration of the year,my project was to identify and determine the haemolytic potential of a pigment that is produced by S.aureus. I used molecular techniques, bioinfomatic analysis,tissue culture techniques and various chemical analysis to help address my project.Examples of Molecular techniques I used during the duration of the year was using restiction enzyme digest, forward and reverse sequencing of part of the plasmid of interest, cloning using the pBad expression kit and PCRsPrograms which I was utilised to address the study was programs such as VectorNTI, NCBI software such as BLAST, BLASTN. use of the website softberry to determine the exonic region of the gene and also transmembrane software prediction such as TMpred.Tissue culture techniques was also learnt to address the question of determining the cytotoxicity of the pigment.The cell lines I worked with are the HeLa cell line and the Human Fibroblast cell line.Chemical analysis such as Mass spectrometry HPLC was carried by myself to determine the structure of the pigment as it was never previously resolved.Hence these are the experiences and techniques which I picked up from the year of research