Jobs at Fresenius Kabi

Description

• Monitoring of micro-organisms at all stages of production to ensure the manufacturing of sterile parenteral products in compliance with laid down standards. 
• Maintain a clean laboratory and cleanroom environment according to procedures.
• Preparation and sampling of all environmental samples and testing according to procedures.
• Administrative duties, such as correct and complete documentation, maintaining of logbooks, procedure updates, archiving and store maintenance (FIFO).
• Ensuring correct use, maintenance and calibration of laboratory equipment e.g. air samplers.
• Assist in training of new laboratory assistants and environmental samplers as required.
• Approval and release of ETO sterilized items for use in the environmentally controlled areas.
• Analysis of Water, Bulk and raw materials for bioburden.
• Reading, interpretation and documentation of all environmental sample result (swabs, contact plates, air counts, settle plates and finger dabs), water and product total viable counts and communicating any out-of-specification (OOS) results to relevant production and quality staff to facilitate OOS investigation, documentation and resolution.
• Administrative duties, such as filing of test results and special requests, assisting with procedure updates, archiving of old test reports, checking co-microbiologist documented calculations and procedure compliance, compiling reports or validation protocols when required.
• Performance of media fill, sterility testing, environment and water sampling and testing when necessary.
• Assist in microbiological monitoring of media fills, environmental observations and identifications.
• Active participation of microbiological related projects which are aimed at reducing OOL results both in the laboratory and production areas.
• From time to time carry out additional tasks within the laboratory that are consistent with the qualification and / or training of the incumbent.
• Assist in the microbial testing required for ETO sterilization process.
• Assist with theoretical and practical assessments of gowning competency qualifications of all FKMSA staff and active participation in the ongoing Aseptic Mentorship Program

Requirements

• B.Sc Microbiology and / or Biotechnology or NTD/HNTD Microbiology / Medical Technology
• A minimum of 1 year experience in the Microbiology field

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Description

• To ensure that the production activity under his / her control is carried out in accordance with all relevant process procedures and production standards while fulfilling daily production targets.
• To ensure Large Volume Parenteral Department meets its production requirements (ito of volume, quality, costs) effectively and efficiently at all times.
• To assist with the Department Manager in production shift planning to commit LVP department to maximum attainment of that plan. 
• To ensure optimum labour utilization for the shift whilst organizing and controlling the day to day production requirements
• To provide input to the department manager re annual department budget and monitor and control adherence in terms of days to day expense control.
• To write, review and update the department’s Standard Operating Procedures and Good Manufacturing Practices.         
• Responsible for continuous improvement in the production area to ensure product and process efficiency and quality.
• Provide support to line specific improvement projects.
• Optimizing maximum efficiency of company resources with minimal reject and waste levels.
• Control department staff discipline including settlement of disputes and grievances, absenteeism, Initiating, disciplinary action access control and timekeeping according to the Company Code of Conduct.
• To commit the shift to comprehensive and on-going training and monitor training level of shift.
• Provide timeous and accurate operational data as required for the monitoring of key indicators.
• To take on ownership of shift KPIs.
• To address non-compliances with BMR/logbook queries and drive RFT from an operations standpoint
• Responsible for shift health and safety processes and conducting Safety Incident investigations.
• Assume delegated responsibility of departmental manager during periods of absence or whilst on shift
• Responsible for implementing continuous improvement initiatives and projects 
• Responsible for Logging and closure of incidents / Deviations / change controls on Kabitrack
• Arriving 15 minutes prior to the shift commencing in order to perform floor walkabout and handover
• From time to time carry out other jobs within the department / factory, which are consistent with the grade, qualification and training of the incumbent

Requirements

• Appropriate tertiary qualification with a minimum National Diploma in either Technical, Pharmaceutical or Production Management fields.
• PMA qualification advantageous
• Minimum 3-5 years experience in Production environment with at least 2 years at supervisory level.
• Computer literate

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Description

• To co-ordinate the total Large Volume Parenteral filling production operation from a pharmaceutical perspective.
• Is conversant and well versed with daily production program.
• Identifies and addresses daily pharmaceutical problems.
• Reports / liaises daily with the Department Manager on the pharmaceutical (production) situation.
• Performs department pharmacy duties.
• Assist the Production Leaders to ensure that all staff is properly trained for their job.
• Writes, reviews up-dates department Standard Operating Procedures and Good Manufacturing Practices.
• To support production department in ensuring that the daily production program and targets are met.
• Responsible for the department compliance with factory rules and regulations.
• Responsible for the maintenance of Good Manufacturing Practices Standards within the department.
• Responsible for the accurate completion and reconciliation of departmental batch book documents.
• Assist the Department Manager with the close out of Deviations, CAPA’s audit findings etc.
• Responsible for the implementation of change controls.
• Responsible to perform investigations in the area of responsibility, with the support of the tool Kabitrack
• Will be required to stand in for Production Leaders in the event of training or absenteeism etc.
• Supervision and training of pharmaceutical staff.
• From time to time carry out other jobs within the department / factory, which are consistent with the grade, qualification and training of the incumbent

Requirements

• B Pharm Tertiary qualification. 
• Registered Pharmacist with South African Pharmacy Council.
• Pharmaceutical manufacturing experience.
• Proven ‘hands – on’ managerial ability
• Production management skills
• Specific Large Volume Parenteral process technical skills
• Human resources / industrial relations skills
• N.O.S.A and MOSACT awareness
• 1 year experience minimum

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Description

• To support the total Large Volume Parenteral production operation from a pharmaceutical perspective under direct supervision of a qualified Production Pharmacist.
• Conversant with daily production program and schedule required pharmaceutical activities accordingly.
• Identifies and addresses daily production problems
• Reports / liaises daily with the production pharmacist and in case of absence with the department manager on the production situation.
• Performs department pharmaceutical duties under the direct supervision of a qualified pharmacist
• Is responsible for department productivity and loss control (labour, money, machines)
• Support in the training of staff.
• Assists the production pharmacist to write, review and update department Standard Operating Procedures and Good Manufacturing Practices.
• Support production department that the daily production program and targets are met.
• Capable of carrying out ‘second line’ management function for staff problems/disputes.
• Responsible for the department compliance with factory rules and regulations.
• Responsible for the maintenance of Good Manufacturing Practices Standards within the department.
• Responsible for the accurate completion and reconciliation of departmental batch book documents
• From time to time carry out other jobs within the department / factory, which are consistent with the grade, qualification and training of the incumbent.
• Understand quality investigation requirements (risk assessments, deviations, change controls. i.e., Kabitrack)
• Batch book documentation requirements
• Understand SOP structure
• Understand production planning process
• Cleanroom gowning competence
• Understand full manufacturing process
• Accuracy/ Attention to detail
• Planning
• Prioritizing
• SOP’s according to Skills Matrix

Requirements

• Registered as Technician with the South African Pharmacy Council plus a 6-months internship
• Pharmaceutical manufacturing experience.
• Human resources / industrial relations skills
• N.O.S.A awareness
• Visual Packaging in LVP or SVP
• 3 months process experience

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Description

• To ensure that the production activity under his / her control is being carried out in accordance with all relevant process procedures and production standards while fulfilling daily production targets.
• Allocate work to subordinates and supervise subordinates in order to ensure all activities in the department are correctly and efficiently undertaken.
• Maintain and promote efficiency and productivity of subordinates through principles of good supervision to include:
• Responsible for tracking, monitoring, and reporting team KPIs (output, downtime, lost time etc.)
• Take corrective actions
• Carries out short interval production control checks
• Maintain department discipline at all times.
• Check on absenteeism and controls subordinate time keeping.
• Perform shift handover to discuss batch or shift specific matters with previous and following shift
• Maintain GMP within the plant.
• Keeps Production Leader/SVP Manager informed on actual and/or potential production/quality/Good Manufacturing Practice related problems or mechanical breakdowns
• Responsible for setting up and operation of equipment.
• Responsible for clean workplace environment including the equipment.
• Relieve In Process Checker when required
• Train identified personnel on all related items relevant to operation and maintenance of the equipment
• Ensure daily target is met
• Checks on necessary batch book completion after and before each process
• Coordination of components and materials required for production.
• Is responsible to ensure the correct disposal of rejects
• Ensure compliance with all Standard Operating Procedure rules and regulations relevant to the process activity.
• Carry out any necessary documentation as per the Standard Operating Procedure (process records, etc.).
• Liaise with the shift Supervisor to ensure that there’s adequate consumables / materials, etc. for process activities at all times.
• From time to time carry out other jobs within the department / factory, which are consistent with the grade, qualification and training of the incumbent

Requirements

• Computer Literate.  Matric qualification.
• Annual renewed, valid Visual Inspector Qualification is mandatory for this role
• Good eyesight is a pre-requisite.  (Pass the medical eye test)
• Technical qualification would receive preference.
• 2-3 years in a production environment, preferably Pharmaceuticals or FMCG.