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.
Key Accountabilities
Operations and Productivity
Responsible for timeous line start up (minimize down time, increase ouput)
Inspection and certification of clean equipment and the completion of the relevant production documentation in accordance with the relevant SOP'S (logbooks, checklist sheet, performance measures)
Strip down and cleaning of equipment according to production documentation and SOP's
Assembly and operation of equipment according to production documentation and SOP's
Storage preparations of cleaning and sanitizing solutions according to SOP's
Maintaining stock levels of consumable items thereby ensuring availability for the use in production
Ensuring availability of cleaning agents
Cleaning of wall panels, floors, windows, auxiliary equipment as per relevant SOP
Conduct start up checklists and regular I.P.C check according to SOP's and as specified in the production documentation
Setting up machine including change over
Ensure adjustments settings on machine to ensure quality product produced efficiently
All work/operation must be carried out as per condition stipulated in the OHS ACT (working safely)
Shift handover - primary operators responsibility of equipment and room per shift
Carry out work related instructions that are issued by the Supervisor Pharmacist according to the relevant documentation e.g BMR/BPR, SOP's protocols or QA approved documentation
Report deviations (Quality and work related) immediately to your supervisor/IPC inspector and shift pharmacist
Reports breakdowns immediately to Supervisor and pharmacist
Ensure breakdowns are timeously attended to by liaising with the fitter/supervisor
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
Participate in training and development programmes and or assist in training of peer trainees (new staff)
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 (to arrive 10 minutes before start of shift on line to communicate with operator)
Documentation
Timeous and correct filing in information on relevant documentation document e.g BMR/BPR Logbooks etc. SOP's and protocols or QA approved document log books verification line diaries
Assist in the drawing up of relevant documentation e.g BMR/BPR, SOP's Protocols, as well as recommendation proposals to existing documentation
Able to write operating/cleaning procedures for equipment/processes
Maintenance
Report to Supervisor if maintenance/equipment checks are conducted according to guidelines specified in the relevant SOP's
Report breakdowns immediately as per SOP
Assist engineering with breakdown when required
Attending to minor breakdowns
Adjustments to machine
Ensure that breakdowns and maintenance are correctly and timeously recorded in the relevant logbooks
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 SOP's
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
Problem solving
Able to detect and analyse deviations in start-up and in process checks and respond
Response will include active involvement with Pharmacist/Supervisor and Engineering to correct deviations
Able to detect and analyse deviations in product during the processing and respond accordingly. Response will include active involvement with the Department head and other relevant department
Able to problem solve, trouble shoot and resolve machine problems
Accountability
Respond solely for the setup and operation of equipment and processes according to validated parameters
Deviation from these parameters will have a negative impact on the product and equipment
For achieving the daily output target and making alternate plans to achieve the target in the events of delays/errors
Monitoring and maintaining overall resource efficiency at acceptable levels
Accountable for equipment used during the shift at your allocated workstation, line/cubicle
Skills & Knowledge
Educational qualifications:
Matric/ Grade 12 (with Mathematics & English)
Added Advantage: National Diploma in Mechanical or Electrical Engineering or equivalent
Relevant experience:
1-3 years relevant experience in a Pharmaceutical Industry
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