Qualification details

FDF30210 - Certificate III in Pharmaceutical Manufacturing (Release 3)

Summary

Releases:
ReleaseStatusRelease date
3 (this release)Current 06/Sep/2012
(View details for release 2) Replaced04/Nov/2011
(View details for release 1) Replaced31/Jan/2011

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Superseded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Is superseded by FBP30818 - Certificate III in Pharmaceutical ManufacturingUpdated to meet Standards for Training Packages Changes to packaging rules, core and elective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

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 columnEssential
BSBCUS301B - Deliver and monitor a service to customersDeliver and monitor a service to customers Elective
BSBSMB301A - Investigate micro business opportunitiesInvestigate micro business opportunities Elective
BSBSMB401A - Establish legal and risk management requirements of small businessEstablish legal and risk management requirements of small business Elective
BSBSMB402A - Plan small business financesPlan small business finances Elective
BSBSMB403A - Market the small businessMarket the small business Elective
BSBSMB404A - Undertake small business planningUndertake small business planning Elective
BSBSMB405B - Monitor and manage small business operationsMonitor and manage small business operations Elective
BSBSMB406A - Manage small business financesManage small business finances Elective
BSBSMB407A - Manage a small teamManage a small team Elective
BSBWRT301A - Write simple documentsWrite simple documents Elective
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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

September 2012: Replacement of superseded imported Units.

November 2011: Update to imported Units, minor edits.

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.

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:

  • FDF20211 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.

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 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

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

MSAENV272B

Participate in environmentally sustainable work practices

ELECTIVE UNITS 

GROUP A 

Complete one (1) Group A Unit

FDFOP3003A

Operate interrelated processes in a production system

FDFOP3004A

Operate interrelated 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

MSAENV272B 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

BSBSMB405B

Monitor and manage small business operations

BSBSMB407A

Manage a small team

LMTGN3007B

Monitor and operate trade waste

MEM13003B

Work safely with industrial chemicals and materials

MSS403011A

Facilitate implementation of competitive systems and practices

MSS403013A

Lead team culture improvement

MSAENV472B

Implement and monitor environmentally sustainable work practices

MSAPMSUP303A

Identify equipment faults

MSAPMSUP330A

Develop and adjust a production schedule

MSL973001A

Perform basic tests

TLIA3015A

Complete receival/despatch documentation

TLIA3016A

Use inventory systems to organise stock control

TLIA3018A

Organise despatch operations

TLIA3019A

Organise receival operations

TLIA3026A

Monitor storage facilities

TLIA3038A

Control and order stock

TLIA3039A

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

BSBCUS301B

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

HLTFA301C

Apply first aid

MSS402010A

Manage the impact of change on own work

MSS403010A

Facilitate change in an organisation implementing competitive systems and practices

MSS402001A

Apply competitive systems and practices

MSS402002A

Sustain process improvements

MSS403002A

Ensure process improvements are sustained

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

MSS403021A

Facilitate a Just in Time system

MSS403023A

Monitor a levelled pull system of operations

MSS403040A

Facilitate and improve implementation of 5S

MSS403041A

Facilitate breakthrough improvements

MSS404050A

Undertake process capability improvements*

MSS404052A Apply statistics to operational processes

MSS403051A

Mistake proof an operational process

MSS404052A

Apply statistics to operational processes

MSS404060A

Facilitate the use of planning software systems in a work area or team

MSS404082A

Assist in implementing a proactive maintenance strategy

MSS404083A

Support proactive maintenance

MSAPMOPS405A

Identify problems in fluid power system

MSAPMOPS406A

Identify problems in electronic control systems

MSAPMPER300C

Issue work permits*

RIIRIS201B Conduct local risk control

MSAPMSUP310A

Contribute to development of plant documentation

MSAPMSUP390A

Use structured problem solving tools

MSL922001A

Record and present data

TAEASS401B

Plan assessment activities and processes

TAEASS402B

Assess competence

TAEASS403B

Participate in assessment validation

TAEDEL301A

Provide work skill instruction

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