مشغل إنتاج المستحضرات المعقمة

Main Responsibilities:

• Operation of sterile machines such as filling machines (vial, ampoule, eye drops), autoclaves, tunnels, manufacturing vessels, freeze dryer.

• Good aseptic behaviour and hygiene.

• Responsible for Media fill activities with concerned departments.
• Follow the instructions of direct supervisor.
• Strictly adhere to the concerned SOP when operating the machine.
• OEE and yield improvements to achieve production KPIs.
• Supporting other production team members for proper understanding and guidance
• Cleaning the area and equipment in accordance with the respective SOPs
• Performing machine changeover and settings according to approved procedures,
support for machine trouble shooting
• Strictly following the procedure for filling/manufacturing as per POI’s requirements and
considering GMP as a standard for all procedures, up on completion of each stage inform
concerned superior to perform verification
• Assuring documentation for all activities online as per approved procedure requirements and GDP.

• Follow the proper hygiene practices and guide production team members to follow the
• Support Engineering, validation and quality teams during re-qualification, validation and calibration.
• Ability for working in rotational shifts Day/Night and weekends.

Qualifications:

• Diploma with NLT 5 years experience in sterile production.

• Proven experience in sterile liquid filling operation (vials and ampoules).

• Strong knowledge of GMP, aseptic processing, and pharmaceutical production standards.

• Strong problem-solving, communication, and documentation skills.

• Willingness to work rotational day/night shifts and weekends as required.

• Preferred experience in:

-Lyophilization (freeze-drying) processes.

-Pre-filled syringe manufacturing.

-Eye drops.

-Sterile compounding.