Certificate II in Pharmaceutical Manufacturing

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.


Subjects

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:

add topic FDFOHS2001A

Participate in OHS processes

add topic FDFOP2064A

Provide and apply workplace information

add topic FDFPH2001A

Apply Good Manufacturing Practice procedures

add topic 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

add topic FDFPH2002A

Operate a concentration process

add topic FDFPH2003A

Operate an extraction process

add topic FDFPH2004A

Operate a separation process using chromatography*

add topic FDFOP2032A Work in a clean room environment

add topic FDFPH2005A

Operate an aseptic fill and seal process*

add topic FDFOP2032A Work in a clean room environment

add topic FDFPH2006A

Operate an aseptic form, fill and seal process*

add topic FDFOP2032A Work in a clean room environment

add topic FDFPH2007A

Coordinate a label store

add topic FDFPH2008A

Operate a compressing process

add topic FDFPH2009A

Dispense pharmaceutical raw materials

add topic FDFPH2010A

Operate an encapsulation process

add topic FDFPH2011A

Operate a granulation process

add topic FDFPH2012A

Operate a liquid manufacturing process

add topic FDFPH2013A

Operate a tablet coating process

add topic FDFPH2014A

Operate a terminal sterilisation process

Cross Sector Units

add topic FDFOP1003A

Carry out manual handling tasks

add topic FDFOP2001A

Work effectively in the food processing industry

add topic FDFOP2002A

Inspect and sort materials and product

add topic FDFOP2003A

Clean equipment in place

add topic FDFOP2004A

Clean and sanitise equipment

add topic FDFOP2006A

Operate a bulk dry goods transfer process

add topic FDFOP2007A

Work in a freezer storage area

add topic FDFOP2008A

Operate a bulk liquid transfer process

add topic FDFOP2009A

Load and unload tankers

add topic FDFOP2010A

Work with temperature controlled stock

add topic FDFOP2011A

Conduct routine maintenance

add topic FDFOP2012A

Maintain food safety when loading, unloading and transporting food

add topic FDFOP2013A

Apply sampling procedures

add topic FDFOP2014A

Participate in sensory analyses

add topic FDFOP2015A

Apply principles of statistical process control*

add topic FDFOP2061A Use numerical applications in the workplace

add topic FDFOP2016A

Work in a food handling area for non-food handlers

add topic FDFOP2017A

Operate a blending, sieving and bagging process

add topic FDFOP2018A

Operate a case packing process

add topic FDFOP2019A

Fill and close product in cans

add topic FDFOP2020A

Operate a form, fill and seal process

add topic FDFOP2021A

Operate a fill and seal process

add topic FDFOP2022A

Operate a high speed wrapping process

add topic FDFOP2023A

Operate a packaging process

add topic FDFOP2024A

Operate a cooling, slicing and wrapping process

add topic FDFOP2025A

Manufacture extruded and toasted products

add topic FDFOP2026A

Operate a forming or shaping process

add topic FDFOP2027A

Dispense non-bulk ingredients

add topic FDFOP2028A

Operate a mixing or blending process

add topic FDFOP2029A

Operate a baking process

add topic FDFOP2030A

Operate a process control interface

add topic FDFOP2031A

Operate a coating application process

add topic FDFOP2032A

Work in a clean room environment*

add topic FDFFS2001A Implement food safety program and procedures OR

add topic FDFPH2001A Apply Good Manufacturing Practice procedures

add topic FDFOP2033A

Operate a depositing process

add topic FDFOP2034A

Operate an evaporation process

add topic FDFOP2035A

Operate an enrobing process

add topic FDFOP2036A

Operate an extrusion process

add topic FDFOP2037A

Operate a filtration process

add topic FDFOP2038A

Operate a grinding process

add topic FDFOP2039A

Operate a frying process

add topic FDFOP2040A

Operate a heat treatment process

add topic FDFOP2041A

Operate a mixing or blending and cooking process

add topic FDFOP2042A

Operate a drying process

add topic FDFOP2043A

Operate an homogenising process

add topic FDFOP2044A

Operate a retort process

add topic FDFOP2045A

Operate pumping equipment

add topic FDFOP2046A

Operate a production process

add topic FDFOP2047A

Operate a portion saw

add topic FDFOP2048A

Pre-process raw materials

add topic FDFOP2049A

Operate a reduction process

add topic FDFOP2050A

Operate a separation process

add topic FDFOP2051A

Operate a spreads production process

add topic FDFOP2052A

Operate a chocolate tempering process

add topic FDFOP2053A

Operate a washing and drying process

add topic FDFOP2054A

Operate a water purification process

add topic FDFOP2055A

Freeze dough

add topic FDFOP2056A

Operate a freezing process

add topic FDFOP2057A

Operate a membrane process

add topic FDFOP2058A

Operate a holding and storage process

add topic FDFOP2059A

Operate a continuous freezing process

add topic FDFOP2060A

Operate an automated cutting process

add topic FDFOP2061A

Use numerical applications in the workplace

add topic FDFPPL2001A

Participate in work teams and groups

add topic FDFSUG222A

Operate a waste water treatment system

add topic MSL973001A

Perform basic tests

add topic MTMPSR203A

Sharpen knives

add topic MTMPSR201C

Vacuum pack product

add topic PMBPROD211B

Operate blow moulding equipment

add topic PMBPROD270B

Operate injection blow moulding equipment

add topic TLIA2009A

Complete and check import/export documentation

add topic TLIA2014A

Use product knowledge to complete work operations

add topic TLIA2021A

Despatch stock

add topic TLIA4025A

Regulate temperature controlled stock

add topic TLID2003A

Handle dangerous goods/hazardous substances

add topic TLID2004A

Load and unload goods/cargo

add topic TLID2010A

Operate a forklift

add topic TLIK2010A

Use infotechnology devices in the workplace

GROUP B

add topic FDFOP2005A

Work in a socially diverse environment

add topic FDFSUG218A

Operate a boiler - basic

add topic BSBITU201A

Produce simple word processed documents

add topic BSBITU202A

Create and use spreadsheets

add topic BSBWOR204A

Use business technology

add topic HLTFA201B

Provide basic emergency life support

add topic MSS402010A

Manage the impact of change on own work

add topic MSS402001A

Apply competitive systems and practices

add topic MSS402002A

Sustain process improvements

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

SIRXFIN201

Balance and secure point-of-sale terminal

add topic SIRXFIN002A

Perform retail finance duties

SIRXMER201

Merchandise products

add topic SIRXRSK001A

Minimise theft

add topic SIRXSLS002A

Advise on products and services


Pathways...

    Pathwaysinto 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.

    Pathwaysfrom the Qualification

    After achieving this Qualification, candidates may undertake FDF30210 Certificate III 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

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.