مطلوب عامل إنتاج لدى أدوية الحكمة في عمان ,الاردن
Operator, Sterile Production
Using company guidelines, the sterile production operator is responsible for the full spectrum of duties in controlled clean rooms. This may include but is not limited to: set-up, operation, sanitization, equipment cleaning, PM activities, etc.
Summarized duties are illustrated below:
- Maintains curriculum gowning qualifications.
- Ability to perform all job duties using acceptable aseptic technique.
- Sets up & operates semi-automated sterile production equipment and support equipment such as fillers, water units and sterilization equipment.
- Completes applicable paperwork and logbook entries for the sterile processing rooms in accordance with approved procedures.
- Follows all written procedures for operation of all sterile APIs equipment.
- Performs clean-up of equipment and room, including walls and floor, as necessary.
- Collects samples, performs fill weight checks and other quality checks, as necessary.
- Assists with preventive maintenance tasks on sterilization and processing equipment, such as inspection and cleaning of machine parts, as may be required.
- Refers process issues to Supervisor or designee.
- Informs supervisor of maintenance and/or safety issues.
- Works overtime with short notice when production requires.
- Performs all other duties as determined by supervisor and management.
- Operation of Sterile APIs Production System.
- Operation of powder Micronization systems.
- Environmental Monitoring (Viable / Non-Viable).
- Performance of Integrity tests (Filtration elements).
- Systematic trouble shooting.
- Performance of OOS investigations related activities as advised by supervisors or management.
- Performance of related plant Validation activities.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily after qualification stages. The requirements listed below are representative of the knowledge, skill, and/or ability required.
Diploma degree in medical alliances fields, chemistry, chemical engineering or equivalent.
Prior aseptic technique / working in clean rooms previous experience is preferred but not required.
Good English and Arabic oral and written communication skills are essential. Must be able to document process issues in a clean, concise manner in accordance with cGMPs and SOPs.
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