Modification History
This Qualification supersedes and is equivalent to FDF20210 Certificate II in Pharmaceutical Manufacturing.
September 2012: Replacement of superseded imported Units.
April 2012: Update of imported SUG Units to new FDFSUG Units. Minor typographical corrections.
November 2011: Update to imported Units, including one non-equivalent Unit. Minor edits.
Description
This Qualification covers the Pharmaceutical Manufacturing specialisation.
Job Roles
The Certificate II in Pharmaceutical Manufacturing targets those working within production or production support roles, such as packing within pharmaceutical manufacturing environments. This Qualification is designed for application in supervised environments where the work is predictable with some basic problem solving requirements.
Additional Qualification advice
Units selected from other Training Packages must be relevant to the work outcome, local industry requirements and the Qualification level.
Many Units in this Qualification assume a basic level of mathematics equivalent to a school sector Year 10 standard. If a student does not possess this level of mathematics then the Unit FDFOP2061A Use numerical applications in the workplace should be selected as part of this Qualification.
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:
- FDF10110 Certificate I in Food Processing or FDF10210 Certificate I in Pharmaceutical Manufacturing
- direct entry
- limited vocational training and/or work experience.
Pathways from the Qualification
After achieving this Qualification, candidates may undertake FDF30210 Certificate III in 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
The following table contains a summary of the employability skills as identified by the Pharmaceutical Manufacturing 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. |
|
Employability Skill |
Industry /enterprise requirements for this Qualification include : |
Communication |
|
Teamwork |
|
Problem-solving |
|
Initiative and enterprise |
|
Planning and organising |
|
Self-management |
|
Learning |
|
Technology |
|
Packaging Rules
This Qualification requires the achievement of twelve (12 ) Units of Competency in accordance with the following rules.
Total Units must include a minimum of seven (7 ) Units coded FDF .
Four (4 ) Core Units
Eight (8 ) Elective Units
Elective selection must include :
- Five (5) Group A elective Units
Three (3 ) remaining elective Units may be selected from :
- Group A elective Units below, not previously selected
- Group B elective Units
- Units from this Training Package, any other nationally endorsed Training Package and accredited course that are packaged at Certificate I level (maximum 1 Unit), Certificate II (maximum 2 Units),and Certificate III level (maximum 1 Unit)
NOTE: Units marked with an asterisk (*) require completion of prerequisite Unit/s which is identified under the Unit.
CORE UNITS
Complete the following four (4) Units:
FDFOHS2001A |
Participate in OHS processes |
FDFOP2064A |
Provide and apply workplace information |
FDFPH2001A |
Apply Good Manufacturing Practice procedures |
MSAENV272B |
Participate in environmentally sustainable work practices |
ELECTIVE UNITS
GROUP A
Select a minimum of five (5) Units from the Sector Specialist and Cross Sector Units below. A minimum of one (1) pharmaceutical manufacturing specialist Unit coded FDFPH must be included in the selection.
Sector Specialist Units |
|
FDFPH2002A |
Operate a concentration process |
FDFPH2003A |
Operate an extraction process |
FDFPH2004A |
Operate a separation process using chromatography* FDFOP2032A Work in a clean room environment |
FDFPH2005A |
Operate an aseptic fill and seal process* FDFOP2032A Work in a clean room environment |
FDFPH2006A |
Operate an aseptic form, fill and seal process* FDFOP2032A Work in a clean room environment |
FDFPH2007A |
Coordinate a label store |
FDFPH2008A |
Operate a compressing process |
FDFPH2009A |
Dispense pharmaceutical raw materials |
FDFPH2010A |
Operate an encapsulation process |
FDFPH2011A |
Operate a granulation process |
FDFPH2012A |
Operate a liquid manufacturing process |
FDFPH2013A |
Operate a tablet coating process |
FDFPH2014A |
Operate a terminal sterilisation process |
Cross Sector Units |
|
FDFOP1003A |
Carry out manual handling tasks |
FDFOP2001A |
Work effectively in the food processing industry |
FDFOP2002A |
Inspect and sort materials and product |
FDFOP2003A |
Clean equipment in place |
FDFOP2004A |
Clean and sanitise equipment |
FDFOP2006A |
Operate a bulk dry goods transfer process |
FDFOP2007A |
Work in a freezer storage area |
FDFOP2008A |
Operate a bulk liquid transfer process |
FDFOP2009A |
Load and unload tankers |
FDFOP2010A |
Work with temperature controlled stock |
FDFOP2011A |
Conduct routine maintenance |
FDFOP2012A |
Maintain food safety when loading, unloading and transporting food |
FDFOP2013A |
Apply sampling procedures |
FDFOP2014A |
Participate in sensory analyses |
FDFOP2015A |
Apply principles of statistical process control* FDFOP2061A Use numerical applications in the workplace |
FDFOP2016A |
Work in a food handling area for non-food handlers |
FDFOP2017A |
Operate a blending, sieving and bagging process |
FDFOP2018A |
Operate a case packing process |
FDFOP2019A |
Fill and close product in cans |
FDFOP2020A |
Operate a form, fill and seal process |
FDFOP2021A |
Operate a fill and seal process |
FDFOP2022A |
Operate a high speed wrapping process |
FDFOP2023A |
Operate a packaging process |
FDFOP2024A |
Operate a cooling, slicing and wrapping process |
FDFOP2025A |
Manufacture extruded and toasted products |
FDFOP2026A |
Operate a forming or shaping process |
FDFOP2027A |
Dispense non-bulk ingredients |
FDFOP2028A |
Operate a mixing or blending process |
FDFOP2029A |
Operate a baking process |
FDFOP2030A |
Operate a process control interface |
FDFOP2031A |
Operate a coating application process |
FDFOP2032A |
Work in a clean room environment* FDFFS2001A Implement food safety program and procedures OR FDFPH2001A Apply Good Manufacturing Practice procedures |
FDFOP2033A |
Operate a depositing process |
FDFOP2034A |
Operate an evaporation process |
FDFOP2035A |
Operate an enrobing process |
FDFOP2036A |
Operate an extrusion process |
FDFOP2037A |
Operate a filtration process |
FDFOP2038A |
Operate a grinding process |
FDFOP2039A |
Operate a frying process |
FDFOP2040A |
Operate a heat treatment process |
FDFOP2041A |
Operate a mixing or blending and cooking process |
FDFOP2042A |
Operate a drying process |
FDFOP2043A |
Operate an homogenising process |
FDFOP2044A |
Operate a retort process |
FDFOP2045A |
Operate pumping equipment |
FDFOP2046A |
Operate a production process |
FDFOP2047A |
Operate a portion saw |
FDFOP2048A |
Pre-process raw materials |
FDFOP2049A |
Operate a reduction process |
FDFOP2050A |
Operate a separation process |
FDFOP2051A |
Operate a spreads production process |
FDFOP2052A |
Operate a chocolate tempering process |
FDFOP2053A |
Operate a washing and drying process |
FDFOP2054A |
Operate a water purification process |
FDFOP2055A |
Freeze dough |
FDFOP2056A |
Operate a freezing process |
FDFOP2057A |
Operate a membrane process |
FDFOP2058A |
Operate a holding and storage process |
FDFOP2059A |
Operate a continuous freezing process |
FDFOP2060A |
Operate an automated cutting process |
FDFOP2061A |
Use numerical applications in the workplace |
FDFPPL2001A |
Participate in work teams and groups |
FDFSUG222A |
Operate a waste water treatment system |
MSL973001A |
Perform basic tests |
MTMPSR203A |
Sharpen knives |
MTMPSR201C |
Vacuum pack product |
PMBPROD211B |
Operate blow moulding equipment |
PMBPROD270B |
Operate injection blow moulding equipment |
TLIA2009A |
Complete and check import/export documentation |
TLIA2014A |
Use product knowledge to complete work operations |
TLIA2021A |
Despatch stock |
TLIA4025A |
Regulate temperature controlled stock |
TLID2003A |
Handle dangerous goods/hazardous substances |
TLID2004A |
Load and unload goods/cargo |
TLID2010A |
Operate a forklift |
TLIK2010A |
Use infotechnology devices in the workplace |
GROUP B
FDFOP2005A |
Work in a socially diverse environment |
FDFSUG218A |
Operate a boiler - basic |
BSBITU201A |
Produce simple word processed documents |
BSBITU202A |
Create and use spreadsheets |
BSBWOR204A |
Use business technology |
HLTFA201B |
Provide basic emergency life support |
MSS402010A |
Manage the impact of change on own work |
MSS402001A |
Apply competitive systems and practices |
MSS402002A |
Sustain process improvements |
MSS402021A |
Apply Just in Time procedures |
MSS402030A |
Apply cost factors to work practices |
MSS402031A |
Interpret product costs in terms of customer requirements |
MSS402040A |
Apply 5S procedures |
MSS402050A |
Monitor process capability |
MSS402051A |
Apply quality standards |
MSS402060A |
Use planning software systems in operations |
MSS402061A |
Use SCADA systems in operations |
MSS402080A |
Undertake root cause analysis |
MSS402081A |
Contribute to the application of a proactive maintenance strategy |
SIRXFIN201 |
Balance and secure point-of-sale terminal |
SIRXFIN002A |
Perform retail finance duties |
SIRXMER201 |
Merchandise products |
SIRXRSK001A |
Minimise theft |
SIRXSLS002A |
Advise on products and services |