Certificate IV in Pharmaceutical Manufacturing

This qualification covers the Pharmaceutical Manufacturing specialisation.

Job Roles The Certificate IV in Pharmaceutical Manufacturing targets those working in supervisory, middle management or those requiring technical roles within pharmaceutical manufacturing environments. Emphasis is on monitoring of pharmaceutical manufacturing systems and procedures with input into management functions of the organisation.

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

FDF30210 Certificate III in Pharmaceutical Manufacturing

direct entry

relevant vocational training and/or work experience.

Pathways from the qualification After achieving this qualification, candidates may undertake the FDF50210 Diploma of 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.

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

Packaging Rules

This qualification requires the achievement of twenty one (21) units of competency in accordance with the following rules.

Total units must include a minimum of eleven (11) units coded FDF.

Seven (7) Core units

Fourteen (14) Elective units

Elective selection must include:

A minimum of one (1) Group A elective unit

A minimum of one (1) Group B elective unit

A minimum of five (5) Specialist Technical Group C elective units

Seven (7) remaining elective units may be selected from:

Group A elective units below, not previously selected

Group B elective units below, not previously selected

Group C elective units below, not previously selected

Group D elective units

Units packaged at FDF20210 Certificate II in Pharmaceutical Manufacturing (maximum of 3)

Units packaged at FDF30210 Certificate III in Pharmaceutical Manufacturing (maximum of 5)

Units packaged at FDF50210 Diploma of Pharmaceutical Manufacturing (maximum of 2)

A maximum of 4 units from any nationally endorsed Training Package and accredited course that are packaged at Certificate II level (maximum 2 units), Certificate III level (maximum 2 units), Certificate IV level (maximum 4 units), and Diploma level (maximum 2 units)

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

CORE UNITS

Complete the following seven (7) units.

add topic FDFPH4001A

Prepare and review workplace documentation to support GMP

add topic FDFPH4002A

Facilitate and monitor Good Manufacturing Practice

add topic FDFPH4003A

Facilitate contamination control

add topic FDFPH4005A

Participate in validation processes

add topic FDFPH4006A

Respond to non-conformance

add topic FDFPPL3002A

Report on workplace performance

add topic MSAENV472A

Implement and monitor environmentally sustainable work practices

ELECTIVE UNITS

Select a minimum of one (1) Group A elective unit.

GROUP A

add topic FDFOHS4001A

Identify, assess and control OHS risk in own work

add topic FDFOHS4002A

Maintain OHS processes

Select a minimum of one (1) Group B elective unit

GROUP B

add topic FDFOP3003A

Operate inter-related processes in a production system

add topic FDFOP3004A

Operate inter-related processes in a packaging system

Select a minimum of five (5) Group C Specialist Technical and Cross Sector elective units.

GROUP C

Specialist Technical units

add topic FDFPH4004A

Participate in change control procedures

add topic FDFPH4005A

Participate in validation processes

add topic FDFPPL4002A

Plan and coordinate maintenance

add topic FDFPPL4004A

Optimise a work process

add topic FDFPPL4005A

Establish process capability

add topic FDFTEC4001A

Determine handling processes for perishable food items

add topic FDFTEC4002A

Manage controlled atmosphere storage

add topic FDFTEC4003A

Control food contamination and spoilage

add topic FDFTEC4004A

Apply basic process engineering principles to food processing*

add topic FDFTEC4007A Describe and analyse data using mathematical principles

add topic FDFOP2030A Operate a process control interface

add topic FDFTEC4005A

Apply an understanding of food additives

add topic FDFTEC4006A

Apply an understanding of legal requirements of food production

add topic FDFTEC4007A

Describe and analyse data using mathematical principles

add topic FDFTEC4008A

Apply principles of food packaging

add topic FDFTEC4009A

Identify the physical and chemical properties of materials, food and related products

add topic FDFTEC4010A

Manage water treatment processes

add topic FDFTEC4011A

Participate in product recalls

add topic MSACMT481A

Undertake proactive maintenance analyses

add topic MSACMT482A

Assist in implementing a proactive maintenance strategy

add topic MSACMT483A

Support proactive maintenance

add topic MSAPMOPS404A

Co-ordinate maintenance

add topic MSAPMOPS405A

Identify problems in fluid power system

add topic MSAPMOPS406A

Identify problems in electronic control systems

add topic MSAPMOPS401A

Trial new process or product

add topic MSAPMOPS400A

Optimise process/plant area

add topic MSAPMSUP390A Use structured problem solving tools

add topic PMASUP420B

Minimise environmental impact of process

add topic PMBTECH406A

Diagnose production equipment problems

Cross Sector units

add topic FDFPPL4001A

Manage people in the work area

add topic FDFPPL4003A

Schedule and manage production

add topic FDFPPL4006A

Manage a work area within budget

add topic FDFPPL4007A

Manage supplier agreements and contracts

add topic FDFPPL4008A

Manage internal audits*

add topic FDFPPL3005A Participate in an audit processes

add topic FDFOHS2001A Participate in OHS processes

add topic FDFFS2001A Implement the food safety program and procedures

add topic MSAENV272A Participate in environmentally sustainable work practices

add topic BSBINN301A

Promote innovation in a team environment

add topic BSBLED401A

Develop teams and individuals

add topic BSBMGT402A

Implement operational plan

add topic BSBMGT403A

Implement continuous improvement

add topic BSBSMB407A

Manage a small team

add topic MSACMC411A

Lead a competitive manufacturing team

add topic MSACMS400A

Implement a competitive manufacturing system

add topic MSACMS401A

Ensure process improvements are sustained

add topic MSACMT430A

Improve cost factors in work practices

add topic MSACMT432A

Analyse manual handling processes

add topic MSACMT450A

Undertake process capability improvements*

add topic MSACMT452A Apply statistics to processes in manufacturing

add topic MSACMT451A

Mistake proof a production process

add topic MSACMT452A

Apply statistics to processes in manufacturing

add topic TAEASS401A

Plan assessment activities and processes

add topic TAEASS402A

Assess competence

add topic TAEASS403A

Participate in assessment validation

add topic TAEDES401A

Design and develop learning programs

GROUP D

add topic FDFOHS2001A

Participate in OHS processes

add topic FDFOP2030A

Operate a process control interface

add topic FDFOP2061A

Use numerical applications in the workplace

add topic FDFOP2063A

Apply quality systems and procedures

add topic FDFPPL3005A

Participate in audit processes

add topic BSBCUS501A

Manage quality customer service

add topic BSBHRM402A

Recruit, select and induct staff

add topic BSBMGT401A

Show leadership in the workplace

add topic BSBRES401A

Analyse and present research information

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 BSBSMB405A

Monitor and manage small business operations

add topic BSBSMB406A

Manage small business finances

add topic BSBWOR401A

Establish effective workplace relationships

add topic BSBWOR402A

Promote team effectiveness

add topic BSBWOR403A

Manage stress in the workplace

add topic BSBWOR404A

Develop work priorities

add topic BSBWRT401A

Write complex documents

add topic MEM15001B

Perform basic statistical quality control

add topic MNMC205A

Conduct local risk assessment

add topic MSACMC410A

Lead change in a manufacturing environment

add topic MSACMC413A

Lead team culture improvement

add topic MSACMS405A

Lead a manufacturing team using a balanced score card approach

add topic MSACMT260A

Use planning software systems in manufacturing

add topic MSACMT261A

Use SCADA systems in manufacturing

add topic MSACMT280A

Undertake root cause analysis

add topic MSACMT421A

Facilitate a Just in Time (JIT) system

add topic MSACMT423A

Monitor a manufacturing levelled pull system*

add topic MSACMT280A Undertake root cause analysis

add topic MSACMT440A

Lead 5S in a manufacturing environment

add topic MSACMT441A

Facilitate continuous improvement in manufacturing

add topic MSACMT453A

Use six sigma techniques*

add topic MSACMT452A Apply statistics to processes in manufacturing

add topic MSACMT460A

Facilitate the use of planning software systems in manufacturing*

add topic MSACMT260A Use planning software systems in manufacturing

add topic MSACMT461A

Facilitate SCADA systems in a manufacturing team or work area*

add topic MSACMT261A Use SCADA systems in manufacturing

add topic MSAENV272A

Participate in environmentally sustainable work practices

add topic MSAPMPER201A

Monitor and control work permits

add topic MSAPMPER300B

Issue work permits*

add topic MNMC205A Conduct local risk assessment

add topic MSAPMPER400A

Coordinate permit process*

add topic MSAPMPER300B Issue work permits

add topic MSAPMSUP310A

Contribute to the development of plant documentation

add topic MSAPMSUP390A

Use structured problem solving tools

add topic RTE4914A

Participate in an e-business supply chain


Pathways...

    Not applicable.


Entry Requirements

Not applicable.


Licensing 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.


Employability Skills

QUALIFICATION SUMMARY

Certificate IV in Pharmaceutical Manufacturing

The following table contains a summary of the Employability Skills as identified by the pharmaceutical manufacturing related 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 workplace documentation and records

Use a range of communication technologies to support work operations

Develop work instructions, specifications and procedures

Demonstrate effective and appropriate communication and interpersonal skills when dealing with people

Communicate with all team members in a professional manner

Demonstrate effective and appropriate documentation, communication and interpersonal skills when dealing with internal and external clients

Use most appropriate communication method given priority, cost and audience needs

Access, interpret and apply technical information

Analyse data and information to determine implications for work operations

Teamwork

Work cooperatively with people of different ages, gender, race or religion

Liaise with and provide support to other team members

Demonstrate leadership skills

Identify and manage performance required to meet internal and external customer needs in own work and team work

Manage organisational processes and provide problem solving support to others

Problem-solving

Investigate problem causes

Identify, rectify or report potential and actual problems associated with work operations

Identify factors which may affect the product or service to be provided

Use material and process knowledge to solve problems

Identify hazards and suggest control measures

Monitor food safety practices

Initiative and enterprise

Gather and analyse feedback on products, processes and procedures

Assess quality and other indicators of products

Support achievement of efficient production processes

Determine and act on situations requiring further information or problem solving

Assist in the implementation of continuous improvement processes

Provide leadership in the workplace

Planning and organising

Identify hazards and implement appropriate hazard control measures

Demonstrate time management skills

Source and prepare materials and resources and ensure availability to support work operations

Schedule and sequence work to maximise safety and productivity

Optimise work processes

Self-management

Interpret and apply relevant acts and regulations

Keep the work area clean and tidy at all times

Monitor own work and work of team and identify and act on any quality issues

Manage own time to meet deadlines

Implement and monitor workplace procedures and instructions

Learning

Implement learning activities as appropriate to ensure achievement of specified work requirements

Be supportive, assertive and use interpersonal skills to encourage workplace learning

Identify own training needs and seek skill development if required

Gather feedback to own work to assess effectiveness in meeting objectives and integrate information into own practice

Assess work data and information to identify areas for improved performance

Technology

Use computer software applications effectively

Work with technology safely and according to workplace standards

Help others use technology efficiently and safely

Ensure readiness and operational efficiency of workplace technology