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Qualification details

FDF30210 - Certificate III in Pharmaceutical Manufacturing (Release 1)

Summary

Usage recommendation:
Superseded
Mapping:
MappingNotesDate
Is superseded by FBP30818 - Certificate III in Pharmaceutical ManufacturingUpdated to meet Standards for Training Packages Changes to packaging rules, core and elective units 17/Dec/2018
Supersedes FDF30203 - Certificate III in Pharmaceutical Manufacturing 30/Jan/2011

Releases:
ReleaseRelease date
(View details for release 3) 06/Sep/2012
(View details for release 2) 04/Nov/2011
1 (this release) 31/Jan/2011

Delivery:
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Training packages that include this qualification

Replaced release

You are currently viewing the components related to release 1.
The current release is release 3.  View release 3 details.

Units of competency

CodeSort Table listing Units of Competency by the Code columnTitleSort Table listing Units of Competency by the Title columnUsage RecommendationSort Table listing Units of Competency by the Usage Recommendation columnEssentialSort Table listing Units of Competency by the Essential column
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FDFOP2061A - Use numerical applications in the workplaceUse numerical applications in the workplaceSupersededN/A
MSACMT280A - Undertake root cause analysisUndertake root cause analysisSupersededN/A
FDFPPL3005A - Participate in an audit processParticipate in an audit processSupersededN/A
MSACMT440A - Lead 5S in a manufacturing environmentLead 5S in a manufacturing environmentSupersededN/A
BSBWRT301A - Write simple documentsWrite simple documentsSupersededN/A
BSBSMB403A - Market the small businessMarket the small businessSupersededN/A
MSACMT450A - Undertake process capability improvementsUndertake process capability improvementsSupersededN/A
MSACMT260A - Use planning software systems in manufacturingUse planning software systems in manufacturingSupersededN/A
MSAPMSUP330A - Develop and adjust a production scheduleDevelop and adjust a production scheduleSupersededN/A
FDFPPL3004A - Lead work teams and groupsLead work teams and groupsSupersededN/A
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Classifications

SchemeCodeClassification value
ANZSCO Identifier 399211 Chemical Plant Operator 
ASCO (occupation type) Identifier 4987-11 Chemical Plant Operator 
ASCED Qualification/Course Field of Education Identifier 0303 Process And Resources Engineering 
Qualification/Course Level of Education Identifier 514 Certificate III 
Taxonomy - Industry Sector N/A Pharmaceutical Production 
Taxonomy - Occupation N/A Pharmaceutical Production Leading Hand 

Classification history

SchemeCodeClassification valueStart dateEnd date
ANZSCO Identifier 399211 Chemical Plant Operator 02/Sep/2011 
ASCO (occupation type) Identifier 4987-11 Chemical Plant Operator 02/Sep/2011 
ASCED Qualification/Course Field of Education Identifier 0303 Process And Resources Engineering 02/Sep/2011 
Qualification/Course Level of Education Identifier 514 Certificate III 31/Jan/2011 
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Modification History

Not applicable.

Description

This qualification covers the Pharmaceutical Manufacturing specialisation.

Job Roles  The Certificate III in Pharmaceutical Manufacturing targets those requiring team leader and higher production skills for pharmaceutical manufacturing environments. It builds upon industry specific skills and knowledge and allows greater emphasis on leadership, problem solving as well as increased technical ability.

Pathways  into the qualification  Pathways for candidates considering this qualification include:

  • FDF20210 Certificate II in Pharmaceutical Manufacturing
  • direct entry
  • relevant vocational training and/or work experience.

Pathways  from the qualification  After achieving this qualification, candidates may undertake the FDF40210 Certificate IV in Pharmaceutical Manufacturing or any other suitable qualification.

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

Not applicable.

Licensing/Regulatory Information

Licensing , Legislative , Regulatory or Certification Considerations  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

EMPLOYABILITY SKILLS QUALIFICATION SUMMARY 

Certificate III in Pharmaceutical Manufacturing 

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
  • Confirm relevant industry and workplace requirements
  • Understand personal and team requirements of relevant industry and workplace standards, regulations and policies
  • Complete standard documentation
  • Use communication technologies efficiently
  • Provide relevant work-related information to others
  • Ensure records are accurate and legible
  • Establish effective working relationships with colleagues
  • Undertake interactive workplace communication
  • Support team communication practices

Teamwork
  • Explain and implement work team reporting requirements
  • Provide support to team members
  • Monitor work team tasks in accordance with regulatory and workplace requirements
  • Demonstrate and encourage others in working cooperatively with people of different ages, gender, race or religion
  • Undertake appropriate and effective communication with team members

Problem-solving
  • Identify risks and implement risk control measures for machinery and equipment
  • Identify and address problems and faults
  • Provide problem solving support to team members
  • Evaluate skill requirements of work tasks
  • Use problem solving techniques to determine work requirements
  • Assess processes and outcomes against quality criteria

Initiative and enterprise
  • Contribute to and promote continuous improvement processes
  • Seek and provide feedback on procedures and processes
  • Collect and assess data and information on work processes
  • Identify non-conformances to standards and take appropriate action
  • Rectify problems promptly and appropriately
  • Monitor and adjust activity in response to operational variations
  • Identify, assess and act on existing and potential risks

Planning and organising
  • Determine work requirements in order to meet output targets
  • Identify priorities and variables that impact on work planning
  • Plan work tasks for self and others as required
  • Allocate tasks to operators and monitor outcomes
  • Implement contingency plan promptly when incidents occur
  • Ensure work tools are ready and available for operations

Self-management
  • Manage own work to meet performance criteria
  • Monitor information in work area
  • Conduct regular housekeeping activities during shift to keep work area clean and tidy at all times
  • Maintain currency of relevant work-related information
  • Monitor own work against quality standards and identify areas for improvement
  • Understand own work activities and responsibilities
  • Identify and apply safety procedures, including the use of protective equipment
  • Manage work load priorities and timelines

Learning
  • Recognise limits of own expertise and seek skill development if required
  • Assess competencies in meeting job requirements
  • Ask questions to expand own knowledge
  • Maintain skill and knowledge currency
  • Participate in meetings to inform work practices

Technology
  • Use work machines and equipment in correct operational mode
  • Monitor machine operation
  • Perform minor maintenance on machinery
  • Work with technology safely and according to workplace standards

Packaging Rules

Packaging Rules 

This qualification requires the achievement of sixteen  (16 ) units of competency in accordance with the following rules.

Total units must include a minimum of nine  (9 ) units coded FDF .

Four  (4 ) Core units 

Twelve  (12 ) Elective units 

Elective selection must include :

  • One (1) Group A elective unit
  • Five (5) Group B elective units. The Group B selection may include the unit not previously selected from Group A.

Six  (6 ) remaining elective units may be selected from :

  • Group A elective units below, not previously selected
  • Group B elective units, not previously selected
  • Group C elective units (maximum of 3 units)
  • Units packaged at Group A in FDF20210 Certificate II in Pharmaceutical Manufacturing (maximum of 5)
  • Units packaged at FDF40210 Certificate in IV in Pharmaceutical Manufacturing (maximum of 3)
  • Units from any nationally endorsed Training Package and accredited course that are packaged at Certificate I level (maximum 1 unit), Certificate II level (maximum 2 units) and Certificate III level (maximum 3)

NOTE: Units marked with an asterisk (*) require completion of prerequisite unit/s identified under the unit.

CORE UNITS 

Complete the following four (4) units.

FDFOHS3001A

Contribute to OHS processes

FDFOP2064A

Provide and apply workplace information

FDFPH3001A

Monitor and maintain Good Manufacturing Practice procedures

MSAENV272A

Participate in environmentally sustainable work practices

ELECTIVE UNITS 

GROUP A 

Complete one (1) Group A unit

FDFOP3003A

Operate inter-related processes in a production system

FDFOP3004A

Operate inter-related processes in a packaging system

GROUP B 

Select a minimum of five (5) Group B elective units

FDFPPL3001A

Participate in improvement processes

FDFPPL3002A

Report on workplace performance

FDFPPL3003A

Support and mentor individuals and groups

FDFPPL3004A

Lead work teams and groups

FDFPPL3005A

Participate in an audit process*

FDFOHS2001A Participate in OHS processes 

FDFOP2063A Apply quality systems and procedures 

MSAENV272A Participate in environmentally sustainable work practices 

FDFPPL3006A

Establish compliance requirements for work area

FDFTEC3002A

Implement the pest prevention program

FDFTEC3003A

Apply raw materials, ingredient and process knowledge to production problems

FDFOP3002A

Set up a production or packaging line for operation

FDFOP2061A

Use numerical applications in the workplace

BSBSMB405A

Monitor and manage small business operations

BSBSMB407A

Manage a small team

LMTGN3007B

Monitor and operate trade waste process

MEM13003B

Work safely with industrial chemicals and materials

MSACMC411A

Lead a competitive manufacturing team

MSACMC413A

Lead team culture improvement

MSAENV472A

Implement and monitor environmentally sustainable work practices

MSAPMSUP303A

Identify equipment faults

MSAPMSUP330A

Develop and adjust a production schedule

MSL973001A

Perform basic tests

TLIA1507C

Complete receival/despatch documentation

TLIA1607C

Use inventory systems to organise stock control

TLIA1807C

Organise despatch operations

TLIA1907C

Organise receival operations

TLIA2607C

Monitor storage facilities

TLIA3807B

Control and order stock

TLIA3907B

Receive and store stock

SIRXINV002A

Maintain and order stock

SIRXRSK002A

Maintain store security

GROUP C 

FDFOHS2001A

Participate in OHS processes

FDFOP2063A

Apply quality systems and procedures

BSBCUS301A

Deliver and monitor a service to customers

BSBSMB301A

Investigate micro business opportunities

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

BSBSMB406A

Manage small business finances

BSBWRT301A

Write simple documents

HLTFA301B

Apply first aid

MSACMC210A

Manage the impact of change on own work

MSACMC410A

Lead change in a manufacturing environment

MSACMS200A

Apply competitive manufacturing practices

MSACMS201A

Sustain process improvements

MSACMS401A

Ensure process improvements are sustained

MSACMT221A

Apply Just in Time (JIT) procedures

MSACMT230A

Apply cost factors to work practices

MSACMT231A

Interpret product costs in terms of customer requirements

MSACMT240A

Apply 5S procedures in a manufacturing environment

MSACMT250A

Monitor process capability

MSACMT251A

Apply quality standards

MSACMT260A

Use planning software systems in manufacturing

MSACMT261A

Use SCADA systems in manufacturing

MSACMT280A

Undertake root cause analysis

MSACMT281A

Contribute to the application of a proactive maintenance strategy

MSACMT421A

Facilitate a Just in Time (JIT) system

MSACMT423A

Monitor a manufacturing levelled pull system*

MSACMT280A Undertake root cause analysis 

MSACMT440A

Lead 5S in a manufacturing environment

MSACMT441A

Facilitate continuous improvement in manufacturing

MSACMT450A

Undertake process capability improvements*

MSACMT452A Apply statistics to processes in manufacturing 

MSACMT451A

Mistake proof a production process

MSACMT452A

Apply statistics to processes in manufacturing

MSACMT460A

Facilitate the use of planning software systems in manufacturing*

MSACMT260A Use planning software systems in manufacturing 

MSACMT482A

Assist in implementing a proactive maintenance strategy

MSACMT483A

Support proactive maintenance

MSAPMOPS405A

Identify problems in fluid power system

MSAPMOPS406A

Identify problems in electronic control systems

MSAPMPER300A

Issue work permits

MSAPMSUP310A

Contribute to development of plant documentation

MSAPMSUP390A

Use structured problem solving tools

MSL922001A

Record and present data

TAEASS401A

Plan assessment activities and processes

TAEASS402A

Assess competence

TAEASS403A

Participate in assessment validation

TAEDEL301A

Provide work skill instruction

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