Production Engineer

+ Follow-up Calibration, Qualification and Validation of equipment and processes

with relevant department (QM, QC) base on technical documentations

+ Control master Documents, distribute copy version to related section to

implement and instruct shift leader, supervisors to control documents. Withdraw

invalid document and destroy according to procedure. Make plan for annual

revising and control the progress of related person. Prepare and maintenance of

SOP for technical processes and assistance for other SOP of Pharma Production

+ Supervise the complying with GMP regulation of production staff, holding a GMP

training for staff if necessary. Prepare for GMP audits and internal checks based

on the last Audit Report and the true situation of Pharma Production

+ Keeps equipment operational by coordinating maintenance and repair services;

following manufacturer's instructions and established procedures; requesting

special service

+ Training: Follow up training and retraining program for all staffs, update new

SOPs, revised SOP and organize training for Pharma Staffs. Educate employees

on proper methods in which to operate machinery.

+ Responsible for following others consumption in production like paper record for

autoclave and conductivity machine; tape dispenser; safety equipment like

facemask and gloves

+ Together Pharma team monitoring quality product on daily production: product

quality, productivity, in-process quality, total quality and scraps

+ Determine which machines, tools, equipment, etc. will be used and where they

will be stationed in the facility

+ Responsible for Cost saving & OpEx activities at Pharma Plant. Increase speed

and efficiency of processes without compromising quality. Design and implement

cost-reductive changes

+ Maximize productivity of machinery and workers.

+ Coordinate safety activities in production area

+ Maintains professional and technical knowledge by attending educational workshops.

The job function listed is not exhaustive and shall include any responsibilities as

assigned by the Superior from time to time.