Shixian Wang Email & Phone Number

Keysborough, VIC, AU

Australia

Melbourne, Victoria, Australia

• Manage validation schedual. Write and execute more than 30 validation protocols for Equipment Qualification, Process Validation, Cleaning Validation and Computer System Validation.
• Perform environmental monitoring quarterly.
• Support the Quality Manager during TGA audit, and assist with closing out CAPAs.
• Raise deviations during validation and environmental monitoring, investigate the root cause and improve the process continuously by implementing CAPAs.
• Review and update SOPs, batch records, operation instructions to ensure the docuemnts comply with GMP requirements.

Melbourne, Victoria, Australia

• Doing batch release on a weekly basis, including review the Batch Record, Analytical Result Reports.
• Manage supplier qualification for more than 20 suppliers, make sure the inward goods are controlled.
• Raise, followed up and review change controls, coordinate with RnD and Production to implement temporary changes for more than 50 batches.
• Raise OOS and Deviations during batch review and investigate the root cause on a daily basis.
• By analysing previous Production Batch Record, Analytical Result Reports and Chang Controls, perform retrospective review for a validated process.
• Collect and analyze data for stability study, and prepare report for shelf-life extention.

Melbourne, Victoria, Australia

• Sampling and analysing of raw materials on a weekly basis, ensure the materials conform to specifications.
• Taking samples of final product for each batch produced, analyse the alkaloid components using HPLC, perform potentiometric titration, LOD, Colour on Dissolution and complete the analytical result report. Up to 10.
• To ensure all analytical equipment used in the testing of intermediate and finished products is qualified, maintained, and calibrated in order to comply with GMP.
• Preparation of primary standards every two months, validate in the HPLC system and generate reports.

Melbourne, Victoria, Australia

• Review the production processes of MHL, performing production process in lab-scale and analysis samples using Ball mill, TGA and DSC.
• Successfully provided a list of suggestions on what could be done to improve the quality of the product, also what further experiments are required for a better product quality.

Master'S Degree, Chemical Engineering

Research Project (Distinction): • The project is to form a crosshatched structure membrane as scaffolds using polymer nanofibers produced.

Bachelor Of Science, Chemistry

Publications: • Preparation of Pt/TiO2 Nanofibers and Their Electrocatalytic Activity towards Methanol Oxidation. Acta Phys. – Chim. Sin..