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Title:  Machine Operator

Job Summary/ Main Purpose

Lactam Machine Operator - the role holder is responsible to adhere with the cGMP principles and to maintain them in an effective manner. Follow instructions, work with other departments, and help ensure that all safety regulations are followed.

Responsible to set up, calibrate, and operate pharmaceutical production machines and equipment, handle minor repair and maintenance on machines as well. This position is responsible to maintain the production equipment for daily use, including cleaning and general equipment troubleshooting.

Key Responsibilities & Key Result Areas

  • Responsible to adhere with the cGMP principles and to maintain them in an effective manner.
  • Perform operations related to any assigned area as per the production plan and as per the SOP & instruction of Shift-In-Charge.
  • Responsible to operate and clean the equipment, instrument or accessories used during the routine production activities as per the SOP.
  • Record the data of cleaning, operations and related works in the respective logs in a timely manner.
  • Set up, calibrate and operate pharmaceutical production machinery at the beginning of each shift, ensuring that any issues are communicated to the supervisor.
  • Ensure the entry of raw materials into the production machine, and ensure that dials are properly regulated.
  • Organizes the machine for  production.
  • Perform all unit dose medication production according to working control form
  • Maintain supplies needed in work station to fulfill services on working control form
  • Performs daily maintenance and necessary adjustments on the production equipment.
  • Troubleshoot line stoppage, aimed at ensuring that downtime is minimized.
  • Handle and oversee inventory of supplies and materials required for production purposes, and ensure that low stock situations are communicated to the supervisor.
  • Perform both preventative and regular maintenance on production machines, and communicate repair needs or damages to the supervisor.
  • Create and maintain logs and correlating documentation, and ensure that any incorrect information is highlighted and reported.
  • Assist in other unit operations as and when required or as instructed by the section head.
  • Maintain hygiene & GMP standards in the area.
  • Perform operations according to the (MFM/BMR) under supervision of supervisor/line boss.
  • Maintain all related logbooks and records.
  • Report any deviation to line Manager
  • Communicate machine problem with senior machine operator and work in co-ordination with maintenance department.

 

Core Competency

  • Experience in:

  1. Compression Machine  

  2. Tablet Coating

  3. Visual inspection Sterile (Semi automatic) / Non Sterile

  4. Granulation 

  5. Blistering machine and Cartooning 

  6. Aseptic Filling in Sterile Area

  7. Aseptic filling preparation 

  8. Lactam operations

 

  • High on Integrity & overall compliance.

  • Positive and approachable manner.

  • Good communication and collaboration with team work.

  • Ability to manage own task on time under supervisor, and commitment.

  • Ability to work under pressure & meet attendance standards. At times it may be necessary to work additional hours in order to accomplish the required tasks to meet deadlines.

  • Detail oriented

 

Qualifications / Key Experiences / Functional Knowledge Requirements

  • Higher Secondary certificate/Diploma in similar field.

  • At least 2 - 4 years' experience in the same filed.

  • Basic Command in English is mandatory & Arabic is a plus (communicating, writing and speaking).

  • Proven experience in Pharmaceutical industry, and product manufacturing.

  • Strong knowledge of GMP Principles, Good Documentation and recording practices.

 

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