Joined CMAB project phase I (50~2000L single use line) as USP lead and report to CMAB validation director, to provide qualification lifecycle management for USP equipment, and support C&Q activities of other systems e.g. DSP, FF, Utility, Facility.1. Drive C&Q activities, define C&Q strategy, develop schedule and track the status.2. Organize external and internal resource to support tests, provide training to package owner for C&Q execution.3. Draft and review C&Q document including SIA/ URS/ CA/ CSA/ CCA/ RA/ RTM/ DQ/ FAT/ SAT/ IOQ and vendor document.4. Provide support to CMAB for risk assessment, change control, PQ and client audit.

Joined AstraZeneca CSSF OSD project as project C&Q lead, reported to AstraZeneca GEP manager.1. Define C&Q strategy and prepare template for C&Q documents, guide package owners for C&Q job.2. Develop C&Q schedule and track status, provide weekly/ monthly report.3. Draft and review vendor document and C&Q document, prepare handover package to client. 4. Take package owner role for coater, organize resource and resolve issues during commissioning.

As a process engineer, start to work for high potent OSD plant project (SHiP II), one of the biggest high containment plant of Roche.Project phase:1. Design review of equipment and utility from user view, FAT, C&Q and punch track , to ensure the project can meet the URS by high quality.2. Local vendor assessment and bidding.3. Organize resource and execute for C&Q.Start-up/routine phase:1. Plan and execution of Naproxen OEL test, PQ, scale-up and PV, CV.2. Create SOPs for plant equipment and routine operation.3. Cross contamination/ multi-production risk assessment, GMP readiness.4. Change control of equipment retrofit including execution and qualification as improvement after project phase.5. Routine plant work including staff management, training, budget control, especially on-site management, audit.

Work as GMP supporter in Roche, mainly responsible for deviation investigation in High Potent Solid manufacturing plant. As a member of cross-function department, coordinate with different function department and reach the final target.Main work:1. Lead the deviation investigation in OSD and packaging plant ,especially for the high potent drugs manufacturing.2. Local SOP updating based on Roche Global standard, set and track the implementation plan.3. Routine monitor the production process from GMP compliance view.

I joined Shanghai Biomerieux during the project phase as QC specialist, and after 2 years i worked as the head of IPC team, mainly responsible for in process control, bio-substrate calibration and application for NIFDC in China market.Main achievement:1. Established the QC test and document system, finished the device qualification.2. Draw up and carry out validation programs. Led the Change Control document and experiment of some key materials such as serum and vials.3. In charge of product approval application for China market; collect and review producing/ quality control records for National Institutes for Food and Drug Control.4. Established the quality trend analysis database, created the key link within different product steps.5. Prepare and calibrate several series of in-house standard sample for product evaluation.

Worked as a researcher in a bio-laboratory for DNA/RNA purification, in charge of process and reagent development and pilot manufacturing.Main achievement:1. Optimize reagent system of protein immobilization on amino-carrier.2. Developed DNA extraction kits using nano particles for blood, plasmid, tissue, PCR product and forensic material.3. Created manufacture and quality control SOPs according to ISO requirement..