Description
Job Summary:
Responsible for aseptic handling, sterilization, and filling of sterile preparations, operating equipment and completing production records.
Key Highlights:
1. Aseptic handling and filling of sterile preparations.
2. Operation of fillers, peristaltic pumps, autoclaves, and ovens.
3. Completion of production and control records.
Description:
* Completed high school education;
* Technical training in the relevant field or prior experience in handling will be an advantage;
* Knowledge of Good Manufacturing Practices (GMP);
* Proficiency in Microsoft Office suite.
* Adhere to hand antisepsis procedures, gowning protocols, and aseptic behavior in cleanrooms, in accordance with Good Manufacturing Practices (GMP);
* Perform aseptic handling, sterilization, and filling of sterile preparations as specified in the preparation order and GMP;
* Manage materials and supplies required to support the production process according to the preparation schedule;
* Operate fillers and peristaltic pumps;
* Operate, load, and unload autoclaves for sterilization of materials and prepared products, per Standard Operating Procedures (SOP);
* Operate and load ovens for depyrogenation of materials, per SOP;
* Assist in preparing materials designated for the sterile area (cleanroom);
* Complete production and control records in compliance with regulatory requirements.
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