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Qualification details

FDF20211 - Certificate II in Pharmaceutical Manufacturing (Release 3)

Summary

Usage recommendation:
Superseded
Mapping:
MappingNotesDate
Is superseded by FBP20418 - Certificate II in Pharmaceutical ManufacturingUpdated to meet Standards for Training Packages Changes to packaging rules, core and elective units 17/Dec/2018
Supersedes FDF20210 - Certificate II in Pharmaceutical Manufacturing 03/Nov/2011

Release Status:
Current
Releases:
ReleaseRelease date
3 (this release) 06/Sep/2012
(View details for release 2) 01/May/2012
(View details for release 1) 04/Nov/2011

Training packages that include this qualification

Units of competency

CodeSort Table listing Units of Competency by the Code columnTitleSort Table listing Units of Competency by the Title columnEssentialSort Table listing Units of Competency by the Essential column
BSBITU201A - Produce simple word processed documentsProduce simple word processed documents Elective
BSBITU202A - Create and use spreadsheetsCreate and use spreadsheets Elective
BSBWOR204A - Use business technologyUse business technology Elective
FDFOHS2001A - Participate in OHS processesParticipate in OHS processes Core
FDFOP1003A - Carry out manual handling tasksCarry out manual handling tasks Elective
FDFOP2001A - Work effectively in the food processing industryWork effectively in the food processing industry Elective
FDFOP2002A - Inspect and sort materials and productInspect and sort materials and product Elective
FDFOP2003A - Clean equipment in placeClean equipment in place Elective
FDFOP2004A - Clean and sanitise equipmentClean and sanitise equipment Elective
FDFOP2005A - Work in a socially diverse environmentWork in a socially diverse environment Elective
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Classifications

SchemeCodeClassification value
ANZSCO Identifier 711911 Chemical Production MacHine Operator 
ASCO (occupation type) Identifier 7293-11 Chemical Production MacHine Operator 
ASCED Qualification/Course Field of Education Identifier 0303 Process And Resources Engineering 
Qualification/Course Level of Education Identifier 521 Certificate II 
Taxonomy - Industry Sector N/A Pharmaceutical Production 
Taxonomy - Occupation N/A Pharmaceutical Production Operator 

Classification history

SchemeCodeClassification valueStart dateEnd date
ANZSCO Identifier 711911 Chemical Production MacHine Operator 12/Apr/2012 
ASCO (occupation type) Identifier 7293-11 Chemical Production MacHine Operator 12/Apr/2012 
ASCED Qualification/Course Field of Education Identifier 0303 Process And Resources Engineering 12/Apr/2012 
Qualification/Course Level of Education Identifier 521 Certificate II 04/Nov/2011 
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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

  • Complete work forms and required written documentation.
  • Use communication and information technologies to support work operations.
  • Demonstrate effective and appropriate interpersonal skills.
  • Interpret and apply workplace procedures and instructions.
  • Share workplace information.
  • Communicate information about problems with work.
  • Communicate information relating to OHS.

Teamwork

  • Work as part of a team.
  • Provide assistance to others in the work area.
  • Identify own role and responsibilities within a team.
  • Identify team goals.
  • Share work-related information.
  • Maintain health and safety of work area for self and others.

Problem-solving

  • Identify and report any workplace hazards.
  • Identify workplace problems and make contributions to their solution.
  • Identify health and safety issues relating to work in the food industry.
  • Apply knowledge of materials, product purpose and processes to work operations.
  • Check performance of machines and equipment and identify signs of faulty operations.
  • Monitor workplace activities and identify and report non-compliances.

Initiative and enterprise

  • Provide feedback on procedures and processes.
  • Gather and interpret information to support safe and efficient work.
  • Ask questions regarding requirements and expectations.
  • Make suggestions for continuous improvement.
  • Inspect quality of work on an ongoing basis.
  • Record basic information on the quality and other indicators of work outcomes.

Planning and organising

  • Identify work requirements and work load priorities.
  • Plan work activities to meet daily work requirements.
  • Direct items to the correct area for further processing.
  • Identify and use relevant personal protective equipment.
  • Organise work area to maintain housekeeping standards.
  • Select and organise relevant equipment and tools.
  • Identify and report issues affecting ability to meet work outcomes.

Self-management

  • Understand own work activities.
  • Identify personal responsibilities.
  • Accept responsibility for quality of own work.
  • Follow OHS and food safety practices.
  • Plan to meet required work outcomes of self and team.
  • Monitor own work.
  • Maintain own work efficiency.
  • Keep the work area clean and tidy at all times.

Learning

  • Assess own competencies in meeting job requirements.
  • Listen to feedback and advice of supervisors.
  • Identify own skill requirements and seek skill development if require.
  • Attend training or skill development activities.
  • Ask questions to expand own knowledge.

Technology

  • Use work tools, machines and equipment safely and effectively.
  • Perform minor maintenance on machinery in accordance with workplace practice.
  • Use manual handling technologies in the workplace.

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