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September 2012: Replacement of superseded imported Units.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 Diploma of Pharmaceutical Manufacturing targets those in senior management, technician or similar roles within pharmaceutical manufacturing industries. It provides extensive skills and knowledge of industry management functions and environment, and the ability to take responsibility for workplace systems.
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:
- FDF40210 Certificate IV in Pharmaceutical Manufacturing
- direct entry
- relevant vocational training and/or work experience.
Pathways from the Qualification
After achieving this Qualification, candidates may undertake a relevant Advanced Diploma 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
Diploma of 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 |
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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 nine (29 ) Units of Competency in accordance with the following rules.
Total Units must include a minimum of eleven (11 ) Units coded FDF .
Nine (9 ) Core Units
Twenty (20 ) Elective Units
Elective selection must include :
- One (1) Group A elective Unit
- One (1) Group B elective Unit
- Six (6) Group C elective Units
- Five (5) Specialist and Cross Sector Units packaged at Certificate IV Group C
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 FDF30210 Certificate III in Pharmaceutical Manufacturing or FDF40210 Certificate IV in Pharmaceutical Manufacturing (maximum of 5)
- Units packaged at FDF20210 Certificate II in Pharmaceutical Manufacturing (maximum of 5)
- 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 3 Units), Diploma or Advanced Diploma level (maximum 3 Units)
NOTE: Units marked with an asterisk (*) require completion of prerequisite Unit/s which is identified under the Unit.
CORE UNITS
Complete the following nine (9) Units:
FDFPH4001A |
Prepare and review workplace documentation to support GMP |
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 |
FDFPPL4001A |
Manage people in the work area |
FDFTEC4007A |
Describe and analyse data using mathematical principles |
MSAENV472B |
Implement and monitor environmentally sustainable work practices |
ELECTIVE UNITS
GROUP A
Select a minimum of one (1) Group A elective Units.
FDFOHS4001A |
Identify, assess and control OHS risk in own work |
FDFOHS5001A |
Manage OHS processes |
GROUP B
Select a minimum of one (1) Group B elective Units.
FDFOP3003A |
Operate inter-related processes in a production system |
FDFOP3004A |
Operate inter-related processes in a packaging system |
GROUP C
Select a minimum of six (6) Group C elective Units.
FDFPPL4003A |
Schedule and manage production |
FDFPPL4007A |
Manage supplier agreements and contracts |
FDFPPL5001A |
Design and maintain programs to support legal compliance |
FDFTEC5001A |
Manage and evaluate new product trials |
FDFTEC5002A |
Manage utilities and energy for a production process |
BSBATSIM507B |
Establish and maintain a strategic planning cycle |
BSBCOM502B |
Evaluate and review compliance |
BSBCOM503B |
Develop processes for the management of breaches in compliance requirements |
BSBMGT502B |
Manage people performance |
BSBMGT515A |
Manage operational plan |
BSBMGT516C |
Facilitate continuous improvement |
BSBPMG510A |
Manage projects |
MEM15001B |
Perform basic statistical quality control |
MSS405011A |
Manage people relationships |
MSS405001A |
Develop competitive systems and practices for an organisation |
MSS405020A |
Develop quick changeover procedures |
MSS405050A |
Determine and improve process capability* MSS404052A Apply statistics to operational processes |
MSS405070A |
Develop and manage sustainable energy practices |
MSACMT671A |
Develop and manage sustainable environmental practices |
GROUP D
BSBCUS501C |
Manage quality customer service |
BSBFIM501A |
Manage budgets and financial plans |
BSBMKG501B |
Identify and evaluate marketing opportunities |
BSBOHS503B |
Assist in the design and development of OHS participative arrangements |
BSBWOR502A |
Ensure team effectiveness |
MSS403010A |
Facilitate change in an organisation implementing competitive systems and practices |
MSS405010A |
Manage relationships with non-customer external organisations |
MSS405012A |
Manage workplace learning |
MSS405013A |
Facilitate holistic culture improvement in an organisation |
MSS405014A |
Develop a communications strategy to support operations |
MSS405002A |
Analyse and map a value stream |
MSS405006A |
Develop a Balanced Scorecard |
MSS405007A |
Introduce competitive systems and practices to a small or medium enterprise |
MSS402030A |
Apply cost factors to work practices |
MSS402080A |
Undertake root cause analysis |
MSS404052A |
Apply statistics to operational processes |
MSS405022A |
Design a process layout |
MSS405023A |
Develop a levelled pull system for operations and processes |
MSS405030A |
Optimise cost of a product or service |
MSS405031A |
Undertake value analysis of product or process costs in terms of customer requirements |
MSS405032A |
Analyse cost implications of maintenance strategy |
MSS405040A |
Manage 5S system in an organisation |
MSS405061A |
Determine and establish information collection requirements and processes |
MSS405062A |
Develop a documentation control strategy for an organisation |
MSS405075A |
Facilitate the development of a new product* MSS404052A Apply statistics to operational processes |
MSS405081A |
Develop a proactive maintenance strategy |
MSS405082A |
Adapt a proactive maintenance strategy to the process operations sector* MSS405081A Develop a proactive maintenance strategy |
MSS405083A |
Adapt a proactive maintenance strategy for a seasonal or cyclical business* MSS405081A Develop a proactive maintenance strategy |
MSS405060A |
Develop the application of enterprise control systems in an organisation |