Process Technicians (Pharmaceutical Manufacturing)

Responsible to operate the plant equipment to manufacture Active Pharmaceutical Ingredients in OSP, Dispensary based on established Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOP).

Perform production raw or intermediate material receiving, staging, material movement, dispensing, sampling, filter inspection, material charging, operating and monitoring of organic synthesis processing equipment as per SOP.

Perform in process sampling, routine de-ioninzed water (DIW) sampling, intermediate and finished goods pack out as per SOP.

Perform pre-campaign set up, post campaign activities and change over cleaning.

Perform start up, routine operations and shutdown of plant auxiliary equipment such as DIW plant, Scrubber system, Emergency Vent system, etc.

Perform panel operation, monitor process trend and alarm using DCS Delta V control system.

Ensure proper communication and handling over of shift duties.

Responsible updating of Manufacturing Standard Work and Operation Standard work.

Complete all documentation including Record of Manual Operation (RMO), Cleaning Instruction (CI), Manufacturing Instruction (MI) according with GMP and GDP standards.

Monitor the plant status and liaise with colleagues of other departments to ensure there is no interruption to manufacturing process.

Troubleshoot all operating deviations and issues and coordinate with other functions when required.

Responsible for preparation and clearing of equipment for maintenance work.

Facilitate shift monthly safety meeting.

Take immediate action to resolve any near miss situations.

Report all actual, near misses and potential accidents for further investigation.

Assist in investigation of all actual, near misses and potential accidents.

Provide information to troubleshoot and take initiative to resolve operational issues independently.

Perform system transaction and operation such as Global Laboratory Information Management System (GLIMS), System Applications and Products in Data Processing (SAP), Material Tracking System (MTS), Enterprise Asset Management System (EMAS), etc.

Complete all required training by attending and completing scheduled training, such as SOP, SOJT, JSA Identify, troubleshoot, resolving and communicate all operating deviations and issues.

Participate as a member of the Emergency Response Team.

Assist in project commissioning and validation activities as necessary.