Job Detail



Specialisation: Manufacturing/Production Operations
Education Qualification: Bachelor Degree
Master Degree
Work Location : Iskandar Puteri, Johor
Salary Range : RM 6,500.00 – 9,000.00
Posted Date : March 15, 2023
1. To plan day to day shift activities in coordination with the superior to and planning in order to achieve production requirements.
2. Prepare / review / train SOP and EOPs related to operations.
3. To ensure that all production activities are carried out in compliance with the cGMP requirements by strictly adhering to the standard operating procedures and good documentation practices.
4. Ensures all team members strictly comply with cGMP procedures.
5. Adherence to safety, health, hygiene and environmental measures.
6. Follow dedicated procedures to enter Drug Product building.
7. Follow dedicated procedures to enter Cleanroom area of Drug Product building as per procedures.
8. Follow dedicated behaviour and hygiene as required in cleanroom area as per procedures.
9. Ensures all team members are properly trained before assigning tasks.
10. Strictly implements line clearance procedure. Escalates any issue immediately to superior.
11. To carry out and ensure that the following activities are performed as per Standard Operating Procedures.
12. To carry out and ensure that the equipment are operated as per Equipment Operating Procedures.

1. Ensure the correctness and accuracy of the data to all the batch records, status labels, checklist, logbooks and other document related to manufacturing activities.
2. Periodically review the log books to ensure that good documentation practices are followed. 
3. Ensure documentation and logbooks are properly maintained in the operation area.
4. Periodically review the SOPs points to ensure that the SOPs reflect current practice.
5. Periodically review Batch Manufacturing Record (BMR) and Batch Packing Report (BPR) to ensure that the BMR and BPR reflect current practice.
6. Support qualification and validation of equipment and process.
7. Supports the Preventive Maintenance and Calibration of Equipment and Instrument to be within due date in coordination with EM and IA.
8. Instructs and ensures all team members in the proper use of required PPEs.
9. Addresses and corrects with audit observations with respect to manufacturing activities.
10. Responsible for manpower management by allocating defined responsibilities to the team members.
11. Responsible for BM/QA/SOP/025 Good Distribution Practices for Medical Device (GDPMD) and ISO 13485 compliance in daily activities. 
12. To record and maintain daily reports.


Kindly contact Mr Hanafi at +60 19-785 1503 for further details or send your resume to []