Certificate III in Pharmaceutical Manufacturing

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.


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.


Complete the following four (4) Units.

add topic FDFOHS3001A

Contribute to OHS processes

add topic FDFOP2064A

Provide and apply workplace information

add topic FDFPH3001A

Monitor and maintain Good Manufacturing Practice procedures

add topic MSAENV272B

Participate in environmentally sustainable work practices



Complete one (1) Group A Unit

add topic FDFOP3003A

Operate interrelated processes in a production system

add topic FDFOP3004A

Operate interrelated processes in a packaging system


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

add topic FDFPPL3001A

Participate in improvement processes

add topic FDFPPL3002A

Report on workplace performance

add topic FDFPPL3003A

Support and mentor individuals and groups

add topic FDFPPL3004A

Lead work teams and groups

add topic FDFPPL3005A

Participate in an audit process*

add topic FDFOHS2001A Participate in OHS processes

add topic FDFOP2063A Apply quality systems and procedures

add topic MSAENV272B Participate in environmentally sustainable work practices

add topic FDFPPL3006A

Establish compliance requirements for work area

add topic FDFTEC3002A

Implement the pest prevention program

add topic FDFTEC3003A

Apply raw materials, ingredient and process knowledge to production problems

add topic FDFOP3002A

Set up a production or packaging line for operation

add topic FDFOP2061A

Use numerical applications in the workplace

add topic BSBSMB405B

Monitor and manage small business operations

add topic BSBSMB407A

Manage a small team

add topic LMTGN3007B

Monitor and operate trade waste

add topic MEM13003B

Work safely with industrial chemicals and materials

add topic MSS403011A

Facilitate implementation of competitive systems and practices

add topic MSS403013A

Lead team culture improvement

add topic MSAENV472B

Implement and monitor environmentally sustainable work practices

add topic MSAPMSUP303A

Identify equipment faults

add topic MSAPMSUP330A

Develop and adjust a production schedule

add topic MSL973001A

Perform basic tests

add topic TLIA3015A

Complete receival/despatch documentation

add topic TLIA3016A

Use inventory systems to organise stock control

add topic TLIA3018A

Organise despatch operations

add topic TLIA3019A

Organise receival operations

add topic TLIA3026A

Monitor storage facilities

add topic TLIA3038A

Control and order stock

add topic TLIA3039A

Receive and store stock

add topic SIRXINV002A

Maintain and order stock

add topic SIRXRSK002A

Maintain store security


add topic FDFOHS2001A

Participate in OHS processes

add topic FDFOP2063A

Apply quality systems and procedures

add topic BSBCUS301B

Deliver and monitor a service to customers

add topic BSBSMB301A

Investigate micro business opportunities

add topic BSBSMB401A

Establish legal and risk management requirements of small business

add topic BSBSMB402A

Plan small business finances

add topic BSBSMB403A

Market the small business

add topic BSBSMB404A

Undertake small business planning

add topic BSBSMB406A

Manage small business finances

add topic BSBWRT301A

Write simple documents

add topic HLTFA301C

Apply first aid

add topic MSS402010A

Manage the impact of change on own work

add topic MSS403010A

Facilitate change in an organisation implementing competitive systems and practices

add topic MSS402001A

Apply competitive systems and practices

add topic MSS402002A

Sustain process improvements

add topic MSS403002A

Ensure process improvements are sustained

add topic MSS402021A

Apply Just in Time procedures

add topic MSS402030A

Apply cost factors to work practices

add topic MSS402031A

Interpret product costs in terms of customer requirements

add topic MSS402040A

Apply 5S procedures

add topic MSS402050A

Monitor process capability

add topic MSS402051A

Apply quality standards

add topic MSS402060A

Use planning software systems in operations

add topic MSS402061A

Use SCADA systems in operations

add topic MSS402080A

Undertake root cause analysis

add topic MSS402081A

Contribute to the application of a proactive maintenance strategy

add topic MSS403021A

Facilitate a Just in Time system

add topic MSS403023A

Monitor a levelled pull system of operations

add topic MSS403040A

Facilitate and improve implementation of 5S

add topic MSS403041A

Facilitate breakthrough improvements

add topic MSS404050A

Undertake process capability improvements*

add topic MSS404052A Apply statistics to operational processes

add topic MSS403051A

Mistake proof an operational process

add topic MSS404052A

Apply statistics to operational processes

add topic MSS404060A

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

add topic MSS404082A

Assist in implementing a proactive maintenance strategy

add topic MSS404083A

Support proactive maintenance

add topic MSAPMOPS405A

Identify problems in fluid power system

add topic MSAPMOPS406A

Identify problems in electronic control systems

add topic MSAPMPER300C

Issue work permits*

add topic RIIRIS201B Conduct local risk control

add topic MSAPMSUP310A

Contribute to development of plant documentation

add topic MSAPMSUP390A

Use structured problem solving tools

add topic MSL922001A

Record and present data

add topic TAEASS401B

Plan assessment activities and processes

add topic TAEASS402B

Assess competence

add topic TAEASS403B

Participate in assessment validation

add topic TAEDEL301A

Provide work skill instruction


    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.

Entry Requirements

Not applicable.

Licensing 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.

Employability Skills

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:


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.


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.


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.


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.


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.


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.