Alexander Yu Email & Phone Number

Oxford, GB

Oxford, England, United Kingdom

• Lead investigator for deviations and root cause analysis, working intra and interdepartmentally to perform efficient investigations and implement effective CAPAs.
• Deputising for the Director of Manufacturing Compliance and Training.
• Managing oversight of departmental records to ensure closure on time and right first time, allowing for batch release as per the schedule.
• Responsible for overseeing the quality management system and quality KPIs within the manufacturing department, collaborating with the different teams to ensure target dates are met and records are completed to a high.
• Working with department leadership to promote GxP compliance and a continuous improvement mindset.
• Assisting the company during client audits, encouraging a year round audit ready approach to ways of working at OXB.

Oxford, England, United Kingdom

• Experienced in lentiviral and adenoviral manufacturing platforms for cell and gene therapy.
• Departmental SME in quality records (Deviations, CAPAs and Change Controls), ensuring timely completion in an efficient and effective manner, allowing for the on time shipping and batch release of the products. One of.
• Responsible for driving a GMP and quality mindset within the manufacturing department, building a right first time attitude.
• Supporting manufacturing by performing observations and GEMBAs of manufacturing processes, ensuring compliance with GMP requirements, whether through BMRs or behaviour.
• Providing the bridge between manufacturing and quality, being heavily involved with deviations and both departments allows for the implementation of value adding CAPAs, which in turn will be reflected in quality metrics.

Maidenhead

• Worked under a GMP environment with extensive experience in the raw materials process including batch review and release.
• Skilled in scheduling work according to production requirements and ensuring materials are released on time.
• Performed lab and vendor investigations including RCA.
• Proficient in using various analytical and physical tests including GC, HPLC, IC, UV-Vis Spectroscopy, Karl Fischer, Raman, Particle Size Analyser, FTIR, XRF, Refractometer, Density, Optical Rotation and Melting Point.
• Responsible for tracking CAPAs within Quality.
• Coordinated change controls and deviations.

Tai Po, Hong Kong

• Responsible for preparation of samples and testing for heavy metals.
• Experience in use of ICP-MS and GC-MS and employed these daily, for use in testing for heavy metals.
• Developed an understanding of how the process of chemical testing works in the professional market.

Master Of Chemistry (Mchem), Chemistry With Medicinal Chemistry, Second Class (Division 1)

4th year chemistry research project: Organocatalytic Generation and Exploitation of Ammonium Enolates 5th year chemistry research project.

Education record