Nur Hayati

- Team member to Material Preparation Team

- Trained in loading and running of Washing Machine

-Trained in setting up vessel and starting of CIP cycles

- POC for supply side

- Train to unload manual cleaning, washing machine and pack small materials according to the matrix given.

- To be able to read material listing from the planner so as to ensure materials and montages can be assembled and delivered on time to the process team

- Assemble sterile and non- sterile assemblies as per SOP

- Able to run Autoclave cycles and ensure sufficient assemblies available for supply

- Perform daily document review

• Follow cGMP and GDP
• Perform Shared function and Upstream daily activities
• Handling of mammalian cell culture
• Trained is Single use technology
• Setting up of wave bags to 2000L bags, welding of new line, sealing of unused lines and setting up of filters
• Trained in hood work/ BSC (Thaw, passaging, Inoculations etc)
• Perform inoculations from flasks to wave bag to 500L and to 2000L vessel
• Train to do feed addition of media addition bulk up of cell culture
• Train to do harvest process
• Perform daily sampling and trained in analytics instruments like PH, Conductivity, Cell Count, Metabolites, TOC, Endotoxin and UPLC
• Perform daily process monitoring
• Perform product change over
• Submission of samples through LIMS
• Trained in using MES and Delta V
• Able to ensure training status maintained at 90%
• Attend shift change meetings and work with external manufacturing support groups for non-routine processes
• Trained in Pallet Jet and Reach Truck
• Ensure good 5S within shop floor
• Raise near misses.

• Follow cGMP and GDP
• To perform daily/weekly/monthly sanitization with cleaning solution that will be prepared
• To perform pre-and post-filter integrity test (Millipore) on various filters and ensure filters meets the specification set
• To do dispensing as per batch production order, collect raw chemicals from warehouse with the use of PAS-X Werum system
• Preparation and start of autoclave load cycle
• Manual set up for equipment preparation Clean-in-place/ Steam-in-place of filling lines, small and large reactor
• Start cycle from HMI/ SCADA, monitor cycle and ensure that cycle completes as per validated parameters
• Moving of portable reactors to holding station or filling station with the use of power tug
• To operate Dry Heat Oven and Parts washer
• Ensure completion of cycle and report generated within specifications
• Compounding of batches: addition of dispensed raw chemicals to mix tank, set agitator speed from HMI, manual set up for sterile transfer to reactor, PH adjustment if necessary and bulk sterilization
• To perform pre- cleaning for isolator and docking of reactor to isolator
• Check for sufficient Hydrogen peroxide prior to start of decontamination cycle
• Upon completion of cycle, perform Aseptic Addition (Grade A) and Final QS reactor to batch weight
• Support MS&T for equipment re-qualifications
• Reviewing of Master batch records prior to submission to QA
• Raise deviations, do the write up and close the deviations - Ensure good 5S within the shop floor
• Raise near misses.

• To perform quality checks on machines
• Ensuring that all screws on machines are tightened, camera on machine is clean with no stains, all barcode labels on pcb boards coincide with the documents provided by the assembling department
• Perform grounding test on machines
• Ensure machine voltage is between 200 to 240 Volts
• Machines that uses 100 Volts or 115 Volts require the use of transformer
• Ensure all parts reflected on Configurable Bills of Materials are installed on machine
• If clients choose to upgrade any parts, ensure all original parts are packed and returned to the client
• Breakdown of machines
• Movable parts are being locked and machines will then be cleaned
• Ensure machines are aesthetically well with no scratches etc
• Machines will then be bubble wrapped
• Final check on machine’s documentation, wrapped folder and placed folder into machine’s door
• Pass machine to the crating department - Ensure good 5S practices and housekeeping of working area.