Modification History
September 2012: Replacement of superseded imported Units.
November 2011: Updates to imported Units, minor edits.
Description
This Qualification covers the Pharmaceutical Manufacturing specialisation.
Job Roles
The Certificate IV in Pharmaceutical Manufacturing targets those working in supervisory, middle management or those requiring technical roles within pharmaceutical manufacturing environments. Emphasis is on monitoring of pharmaceutical manufacturing systems and procedures with input into management functions of the organisation.
Additional Qualification advice
Units selected from other Training Packages must be relevant to the work outcome, local industry requirements and the Qualification level.
Note: AgriFood Skills Australia expects that the design of any training delivery and assessment program to support the achievement of this Qualification is based on:
- the context required by the industry and/or enterprise
- a holistic and integrated training delivery and assessment plan that identifies learning activities and evidence required
- flexible delivery options including on-the-job and work-based training that support the development of competency.
Pathways Information
Pathways into the Qualification
Pathways for candidates considering this qualification include:
- FDF30210 Certificate III in Pharmaceutical Manufacturing
- direct entry
- relevant vocational training and/or work experience.
Pathways from the Qualification
After achieving this ualification, candidates may undertake the FDF50210 Diploma of Pharmaceutical Manufacturing or any other suitable Qualification.
Licensing/Regulatory Information
There is no direct link between this Qualification and licensing, legislative and/or regulatory requirements. However, an individual Unit of Competency may specify relevant licensing, legislative and/or regulatory requirements. In addition, all work must comply with Good Manufacturing Practice, occupational health and safety (OHS) and environmental regulations and legislation that apply to the workplace.
Entry Requirements
Not applicable.
Employability Skills Summary
Certificate IV in Pharmaceutical Manufacturing The following table contains a summary of the Employability Skills as identified by the pharmaceutical manufacturing related industries for this Qualification. This table should be interpreted in conjunction with the detailed requirements of each Unit of Competency packaged in this Qualification. The outcomes described here are broad industry requirements that reflect skill requirements for this level. |
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Employability Skill |
Industry /enterprise requirements for this Qualification include : |
Communication |
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Teamwork |
|
Problem-solving |
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Initiative and enterprise |
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Planning and organising |
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Self-management |
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Learning |
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Technology |
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Packaging Rules
This Qualification requires the achievement of twenty one (21 ) Units of Competency in accordance with the following rules.
Total Units must include a minimum of eleven (11 ) Units coded FDF .
Seven (7 ) Core Units
Fourteen (14 ) Elective Units
Elective selection must include :
- A minimum of one (1) Group A elective Unit
- A minimum of one (1) Group B elective Unit
- A minimum of five (5) Specialist Technical Group C elective Units
Seven (7 ) remaining elective Units may be selected from :
- Group A elective Units below, not previously selected
- Group B elective Units below, not previously selected
- Group C elective Units below, not previously selected
- Group D elective Units
- Units packaged at FDF20210 Certificate II in Pharmaceutical Manufacturing (maximum of 3)
- Units packaged at FDF30210 Certificate III in Pharmaceutical Manufacturing (maximum of 5)
- Units packaged at FDF50210 Diploma of Pharmaceutical Manufacturing (maximum of 2)
- A maximum of 4 Units from any nationally endorsed Training Package and accredited course that are packaged at Certificate II level (maximum 2 Units), Certificate III level (maximum 2 Units), Certificate IV level (maximum 4 Units), and Diploma level (maximum 2 Units)
NOTE: Units marked with an asterisk (*) require completion of prerequisite Unit/s identified under the Unit.
CORE UNITS
Complete the following seven (7) Units.
FDFPH4001A |
Prepare and review workplace documentation to support Good Manufacturing Practice |
FDFPH4002A |
Facilitate and monitor Good Manufacturing Practice |
FDFPH4003A |
Facilitate contamination control |
FDFPH4005A |
Participate in validation processes |
FDFPH4006A |
Respond to non-conformance |
FDFPPL3002A |
Report on workplace performance |
MSAENV472B |
Implement and monitor environmentally sustainable work practices |
ELECTIVE UNITS
Select a minimum of one (1) Group A elective Unit.
GROUP A
FDFOHS4001A |
Identify, assess and control OHS risk in own work |
FDFOHS4002A |
Maintain OHS processes |
Select a minimum of one (1) Group B elective Unit
GROUP B
FDFOP3003A |
Operate interrelated processes in a production system |
FDFOP3004A |
Operate interrelated processes in a packaging system |
Select a minimum of five (5) Group C Specialist Technical and Cross Sector elective Units.
GROUP C
Specialist Technical units |
|
FDFPH4004A |
Participate in change control procedures |
FDFPH4005A |
Participate in validation processes |
FDFPPL4002A |
Plan and coordinate maintenance |
FDFPPL4004A |
Optimise a work process* FDFPPL3001A Participate in improvement processes |
FDFPPL4005A |
Establish process capability* FDFOP2015A Apply principles of statistical process control FDFOP2061A Use numerical applications in the workplace FDFTEC4007A Describe and analyse data using mathematical principles |
FDFTEC4001A |
Determine handling processes for perishable food items |
FDFTEC4002A |
Manage controlled atmosphere storage |
FDFTEC4003A |
Control food contamination and spoilage* FDFFS3001A Monitor the implementation of quality and food safety programs |
FDFTEC4004A |
Apply basic process engineering principles to food processing* FDFOP2030A Operate a process control interface FDFTEC4007A Describe and analyse data using mathematical principles |
FDFTEC4005A |
Apply an understanding of food additives |
FDFTEC4006A |
Apply an understanding of legal requirements of food production |
FDFTEC4007A |
Describe and analyse data using mathematical principles* FDFOP2015A Apply principle of statistical process control FDFOP2061A Use numerical applications in the workplace |
FDFTEC4008A |
Apply principles of food packaging |
FDFTEC4009A |
Identify the physical and chemical properties of materials, food and related products |
FDFTEC4010A |
Manage water treatment processes* MSAENV272B Participate in environmentally sustainable work practices |
FDFTEC4011A |
Participate in product recalls* FDFFS3001A Monitor the implementation of quality and food safety programs |
MSS404081A |
Undertake proactive maintenance analyses |
MSS404082A |
Assist in implementing a proactive maintenance strategy |
MSS404083A |
Support proactive maintenance |
MSAPMOPS404A |
Co-ordinate maintenance |
MSAPMOPS405A |
Identify problems in fluid power system |
MSAPMOPS406A |
Identify problems in electronic control systems |
MSAPMOPS401A |
Trial new process or product |
MSAPMOPS400A |
Optimise process_plant area* MSAPMSUP390A Use structured problem solving tools |
PMASUP420B |
Minimise environmental impact of process |
PMBTECH406A |
Diagnose production equipment problems |
Cross Sector units |
|
FDFPPL4001A |
Manage people in the work area* FDFPPL3003A Support and mentor individuals and groups |
FDFPPL4003A |
Schedule and manage production |
FDFPPL4006A |
Manage a work area within budget |
FDFPPL4007A |
Manage supplier agreements and contracts |
FDFPPL4008A |
Manage internal audits* FDFOHS2001A Participate in OHS processes FDFOP2063A Apply quality systems and procedures FDFPPL3005A Participate in an audit process MSAENV272B Participate in environmentally sustainable work practices |
BSBINN301A |
Promote innovation in a team environment |
BSBLED401A |
Develop teams and individuals |
BSBMGT402A |
Implement operational plan |
BSBMGT403A |
Implement continuous improvement |
BSBSMB407A |
Manage a small team |
MSS403001A |
Implement competitive systems and practices |
MSS403002A |
Ensure process improvements are sustained |
MSS403011A |
Facilitate implementation of competitive systems and practices |
MSS403030A |
Improve cost factors in work practices |
MSS403032A |
Analyse manual handling processes |
MSS403051A |
Mistake proof an operational process |
MSS404050A |
Undertake process capability improvements* MSS404052A Apply statistics to operational processes |
MSS404052A |
Apply statistics to operational processes |
TAEASS401B |
Plan assessment activities and processes |
TAEASS402B |
Assess competence |
TAEASS403B |
Participate in assessment validation |
TAEDES401A |
Design and develop learning programs |
GROUP D
FDFOHS2001A |
Participate in OHS processes |
FDFOP2030A |
Operate a process control interface |
FDFOP2061A |
Use numerical applications in the workplace |
FDFOP2063A |
Apply quality systems and procedures |
FDFPPL3005A |
Participate in audit processes |
AHCBUS405A |
Participate in an e-business supply chain |
BSBCUS501C |
Manage quality customer service |
BSBHRM402A |
Recruit, select and induct staff |
BSBMGT401A |
Show leadership in the workplace |
BSBRES401A |
Analyse and present research information |
BSBSMB401A |
Establish legal and risk management requirements of small business |
BSBSMB402A |
Plan small business finances |
BSBSMB403A |
Market the small business |
BSBSMB404A |
Undertake small business planning |
BSBSMB405B |
Monitor and manage small business operations |
BSBSMB406A |
Manage small business finances |
BSBWOR401A |
Establish effective workplace relationships |
BSBWOR402A |
Promote team effectiveness |
BSBWOR403A |
Manage stress in the workplace |
BSBWOR404B |
Develop work priorities |
BSBWRT401A |
Write complex documents |
MEM15001B |
Perform basic statistical quality control |
MSS402060A |
Use planning software systems in operations |
MSS402061A |
Use SCADA systems in operations |
MSS402080A |
Undertake root cause analysis |
MSS403005A |
Facilitate use of a Balanced Scorecard for performance improvement |
MSS403010A |
Facilitate change in an organisation implementing competitive systems and practices |
MSS403013A |
Lead team culture improvement |
MSS403021A |
Facilitate a Just in Time system |
MSS403023A |
Monitor a levelled pull system of operations |
MSS403040A |
Facilitate and improve implementation in 5S |
MSS403041A |
Facilitate breakthrough improvements |
MSS404053A |
Use six sigma techniques* MSS404052A Apply statistics to operational processes |
MSS404060A |
Facilitate the use of planning software systems in a work area or team |
MSS404061A |
Facilitate the use of SCADA systems in a team or work area |
MSAENV272B |
Participate in environmentally sustainable work practices |
MSAPMPER201A |
Monitor and control work permits |
MSAPMPER300C |
Issue work permits* RIIRIS201B Conduct local risk control |
MSAPMPER400A |
Coordinate permit process* MSAPMPER300C Issue work permits* RIIRIS201B Conduct local risk control |
MSAPMSUP310A |
Contribute to the development of plant documentation |
MSAPMSUP390A |
Use structured problem solving tools |
RIIRIS201B |
Conduct local risk control |