Operator 4

Division

CMM

Department

Manufacturing

Employment Type

Permanent

Job Purpose

Executes production activities by operating machinery and equipment under the supervision of the Production Supervisors, Pharmacists and Pharmacist Assistants. Implements the production plan and targets according to prescribed BMRs, SOPS and cGMP, while maintaining the highest level of Quality, Safety and Productivity.

Accountabilities

Operations and Productivity 1

• Responsible for timeous line start up
• Inspection and certification of clean equipment and the completion of the relevant production documentation in accordance with the relevant SOPS
• Strip down , cleaning, Assemble and Operation of equipment according to production documentation and SOPs
• Storage preparations of cleaning and sanitizing solutions according to SOPs
• Maintaining stock levels of consumable items thereby ensuring availability for the use in production
• Ensuring availability of cleaning agents and Cleaning of wall panels, floors, windows equipment as per SOP
• Conduct start up checklists and regular I.P.C check according to SOPs and as specified in the production documentation
• Ensure adjustments settings on machine to ensure quality product produced efficiently
• All work must be carried out as per condition stipulated in the OHS ACT
• Report deviations immediately to your supervisor/IPCinspector and shift pharmacist
• Ensure breakdowns are timeously attended to by liaising with the fitter/supervisor and reported to Pharmacist

Accountabilities 2

Operations and Productivity 2

• Participate in production Optimization minimise waste, quick change over, identification and resolve delays/ constraints before they occur, contribute to downtime minimization ensure that all material/documents tools and equipment are available
• Is responsible for carrying out line set up process and must ensure accuracy and correctness of all material issued to a job as per BMR/BPR and Syspro document
• Ensure functional integrity and safety of machine before use and report any abnormality or defect immediately to your Supervisor/Pharmacist
• Report component that are of in consistent quality and defects immediately to supervisor, IPC inspector and or shift pharmacist
• Timeous and correct filing in of information on relevant documentation
• Operation of machine as per good engineering practices
• Continuous monitoring of quality of products to ensure specification as per Quality Standards are met, and reporting any deviations immediately
• To be competent in operational, cleaning of equipment as per SOP
• Complete practical assessment and to be found competent
• Conduct shift handover between operators.

Accountabilities 3

Documentation

• Timeous and correct filing in information on relevant documentation document e.g BMR/BPR Logbooks etc. SOPs and protocols or QA approved document log books verification line diaries
• Assist in the drawing up of relevant documentation e.g BMR/BPR, SOPs Protocols, as well as recommendation proposals to existing documentation
• Able to write operating/cleaning procedures for equipment/processes

GMP and Safety

• Maintenance and adherence to cGMP/PICS and safety standards in the department
• Active participation and liaisons in internal and external quality audits
• Ensure competency on all relevant SOPs

Operational Planning

• Plan daily activities in order to meet the agreed daily production targets at respective areas
• Meeting required ORE scores

Communication

• Actively participate in regular team meeting and shift handovers

Education Qualification

Matric/ Grade 12 (with Mathematics & English)

Added Advantage: National Diploma in Mechanical or Electrical Engineering or equivalent

Relevant Work Experience

1-3 years relevant experience in a Pharmaceutical Industry

Job Location

Durban (Mobeni)

Shift Hours

06:00 -14:00

14:00 -22:00

22:00 -06:00