Job Description (JD)
| Nama Program | Ethlene Oxide (ETO) Sterilization Operation [MP-013-3:2013] |
|---|---|
| Kod CU | MP-013-3:2013-C03 |
| Competency | Core |
| Tajuk CU | ETO STERILIZATION QUALITY ASSURANCE |
| Penerangan CU | This competency unit describes the skills, knowledge and attitude requirements to comply with customer and international standard requirement in ETO sterilization operation. The person who is competent in ETO sterilization operations Quality Assurance shall be able to gather Quality System auditing files, handle customer feedback/complaint, carry out calibration activities, investigate and propose preventive and corrective actions for product and process non conformance, perform BI test, report result and compile sterilization batch reports, verify installation qualification, carry out operational qualification activities, and performance qualification activities. The outcome of this competency is to provide excellent ETO sterilization operations Quality Assurance to ensure all the activities are understood, implemented and maintained for optimum effectiveness in the validation process according to organizational requirements and International Quality System. Sterilization is a special process whereby sterile status of the product cannot be directly tested. Therefore sterility assurance level is achieved by close monitoring of the |
| Tempoh Latihan | 1450 |
| Objektif Pembelajaran | The person who is competent in this CU shall be able to provide excellent ETO sterilization Quality Assurance to ensure all the activities are understood, implemented and maintained for optimum effectiveness in the ETO sterilization batch release and validation process according to organization, customer’s and international standards requirements. Upon completion of this competency unit, trainees will be able to :- 1. Gather Quality System auditing files 2. Handle customer feedback/complaint 3. Carry out calibration activities 4. Investigate and propose preventive and corrective actions for product and process non conformance. 5. Perform BI test, report result and compile sterilization batch records 6. Verify Installation qualification (IQ) 7. Carry out Operational qualification (OQ) activities 8. Carry out Performance qualification (PQ)activities |
| Pra-Syarat | 0 |