- Cyberjaya Selangor Malaysia
工作地点
职位描述
岗位职责
Assist the Head of Quality Department and his/her assigned nominees) on the following (but not limited to) matters:-
- Responsible in the operational techniques and activities used to fulfill the requirements for quality control.
- Conduct quality control activities for the products of the Company in accordance to the SOP i.e. colony-forming unit (CFU) assay, flow cytometry analysis, etc.
- Conduct testing for Bacterial Endotoxin and Mycoplasma for all relevant product in the company.
- Conduct quality control testing for products (Mesenchymal Stem Cells, CAR-T, etc).
- Adhere to the SOP at all times as well as ensure compliance with the safety and health regulations of the laboratory at all times.
- Manage and monitor the internal quality controls and the Inter-laboratory Comparison programmes such as external quality assessment programmes or proficiency testing programmes.
- Prepare and record the data analysis for all quality control tests.
- Ensure the validation analyses for cleaning, disinfectant, gowning, process and personnel are carried out accordingly.
- Check the calibration data of equipment or facilities given by internal and external parties.
- Conduct and monitor environmental testing for the facilities.
- Responsible in the continual improvement of the Quality Management System.
- Perform other related laboratory processes such as viability tests, cell culture, blood cell count, etc.
- Maintain all standards as per requirements of the ISO15189, MOH License, cGMP and other certifications/accreditations.
- Participate in internal and external audits as well as regulation inspections.
-Provide adequate trainings to new and existing employees in the department from time to time.
- Other duties as and when requested by the Company.
Job Type: Full-time
Pay: RM2,600.00 - RM2,700.00 per month
Benefits:
Ability to commute/relocate:
Work Location: In person
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