- Kampong Tampoi, Johor Johor Bahru Johor Malaysia
工作地点
职位描述
岗位职责
Summary of Job Scope:
1. Responsible/ assist for qualification of production equipment, premise and critical utilities.
2. Responsible/ assist for process validation, cleaning validation, clean equipment hold time, dirty equipment hold time and hold time study.
3. Prepare validation/ qualification protocols and report.
4. Assist in investigation and follow up production issues and deviations.
5. Responsible to draft, review and revise SOP and procedure for QA department and provide training.
6. Support internal audits to ensure procedures and practices are in line with GMP requirements.
7. Monitor SWJB production process whenever required.
8. Provide basic GMP training.
9. Performed review on the calibration certificate of equipment and device.
10. Perform review on the calibration certificate of equipment and device.
11. Support internal audit and ensure procedures and practices are in line with requirements.
12. Perform tasks as per instructed by superior whenever required.
Requirements:
1. Minimum bachelor's degree or Professional Degree in Science/ Pharmaceutical or equivalent.
2. Knowledge of Quality Management System, e.g., GMP/ISO9001/ etc. is an added advantage.
3. Well versed in documentation handling.
4. Excellent communication and writing skills.
5. Computer literature.
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