Pinqian Zhang

•Coordinate and initiate purchase of materialsfor QC usage which includes consumables, reagents, test media, test cultures, small equipment,glassware, plasticware etc

•Participate in creating SOP, reviewing SOP when necessary

•Support in the timely resolution of issues, including discrepancies, investigations andimplementation of CAPAs.

•Growth Promotion Test and Environmental Monitoring method validation.

•EM equipment qualification

•To conduct training as subject matter expert in the test methods, systems and equipmentassigned.

• Perform routine/qualification testing (which includes microbiological, chemical and biochemicaltesting) of water samples, raw materials, In-process samples and finished product (API)

•Perform environmental monitoring testing as per current SOPs

•Perform equipment calibration/maintenance and troubleshooting of QC laboratory equipment

•Plot EM Trend Graph

•Manage all laboratory related documents to ensure that they are available and up-to-date.

•Perform routine microbiological testing

•Initiate and investigate GEMS event via Trackwise system and Laboratory Investigation Report(LIR).

•Create and revise document (SOP/Testing form).

•To review testing packages and protocol.

•Perform EM trend report writing

•To participate in Lab Segregation Project. Project milestone includes of new equipment qualification, existing lab equipment relocation,new workflow of lab activities and revision of related documents.

• Perform final product inspection (including post autoclave audit, final product audit, sterilization verification, re-sort check and documentation verification).

• Administer laboratory activities (calibration, maintenance, documentation, inventory, etc) to support implementation of assigned projects.

• Perform exception handing such as Non-Conformance Report initiation and product quarantine activities.

• Perform various environmental monitoring/sampling (Water, clean room monitoring, biological
safety cabinets, personnel) in accordance to cGMP procedures.

• Perform water testing for process water. Water testing includes Bioburden, Endotoxin and visual
appearance testing.

• Perform all required data entries into LIMS(Integrated Laboratory System) and GMP documents