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Qualification details

FDF40210 - Certificate IV in Pharmaceutical Manufacturing (Release 1)

Summary

Usage recommendation:
Superseded
Mapping:
MappingNotesDate
Is superseded by FBP40518 - Certificate IV in Pharmaceutical ManufacturingUpdated to meet Standards for Training Packages The number of units to achieve the qualification reduced from 21 to 16 Changes to packaging rules, core and elective units 17/Dec/2018
Supersedes FDF40207 - Certificate IV 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

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BSBCUS501A - Manage quality customer serviceManage quality customer serviceSupersededN/A
BSBHRM402A - Recruit, select and induct staffRecruit, select and induct staffSupersededN/A
BSBINN301A - Promote innovation in a team environmentPromote innovation in a team environmentSupersededN/A
BSBLED401A - Develop teams and individualsDevelop teams and individualsSupersededN/A
BSBMGT401A - Show leadership in the workplaceShow leadership in the workplaceSupersededN/A
BSBMGT402A - Implement operational planImplement operational planSupersededN/A
BSBMGT403A - Implement continuous improvementImplement continuous improvementSupersededN/A
BSBRES401A - Analyse and present research informationAnalyse and present research informationSupersededN/A
BSBSMB401A - Establish legal and risk management requirements of small businessEstablish legal and risk management requirements of small businessSupersededN/A
BSBSMB402A - Plan small business financesPlan small business financesSupersededN/A
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Classifications

SchemeCodeClassification value
ANZSCO Identifier 399999 Technicians And Trades Workers Nec 
ASCO (occupation type) Identifier 3999-79 Associate Professionals Nec 
ASCED Qualification/Course Field of Education Identifier 0303 Process And Resources Engineering 
Qualification/Course Level of Education Identifier 511 Certificate IV 
Taxonomy - Industry Sector N/A Pharmaceutical Production 
Taxonomy - Occupation N/A Pharmaceutical Production Supervisor 

Classification history

SchemeCodeClassification valueStart dateEnd date
ANZSCO Identifier 399999 Technicians And Trades Workers Nec 02/Sep/2011 
ASCO (occupation type) Identifier 3999-79 Associate Professionals Nec 02/Sep/2011 
ASCED Qualification/Course Field of Education Identifier 0303 Process And Resources Engineering 02/Sep/2011 
Qualification/Course Level of Education Identifier 511 Certificate IV 31/Jan/2011 
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Modification History

Not applicable.

Description

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.

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 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

Packaging Rules

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.

FDFPH4001A

Prepare and review workplace documentation to support GMP

FDFPH4002A

Facilitate and monitor Good Manufacturing Practice

FDFPH4003A

Facilitate contamination control

FDFPH4005A

Participate in validation processes

FDFPH4006A

Respond to non-conformance

FDFPPL3002A

Report on workplace performance

MSAENV472A

Implement and monitor environmentally sustainable work practices

ELECTIVE UNITS 

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

GROUP A 

FDFOHS4001A

Identify, assess and control OHS risk in own work

FDFOHS4002A

Maintain OHS processes

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

GROUP B 

FDFOP3003A

Operate inter-related processes in a production system

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 

FDFPH4004A

Participate in change control procedures

FDFPH4005A

Participate in validation processes

FDFPPL4002A

Plan and coordinate maintenance

FDFPPL4004A

Optimise a work process

FDFPPL4005A

Establish process capability

FDFTEC4001A

Determine handling processes for perishable food items

FDFTEC4002A

Manage controlled atmosphere storage

FDFTEC4003A

Control food contamination and spoilage

FDFTEC4004A

Apply basic process engineering principles to food processing*

FDFTEC4007A Describe and analyse data using mathematical principles 

FDFOP2030A Operate a process control interface 

FDFTEC4005A

Apply an understanding of food additives

FDFTEC4006A

Apply an understanding of legal requirements of food production

FDFTEC4007A

Describe and analyse data using mathematical principles

FDFTEC4008A

Apply principles of food packaging

FDFTEC4009A

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

FDFTEC4010A

Manage water treatment processes

FDFTEC4011A

Participate in product recalls

MSACMT481A

Undertake proactive maintenance analyses

MSACMT482A

Assist in implementing a proactive maintenance strategy

MSACMT483A

Support proactive maintenance

MSAPMOPS404A

Co-ordinate maintenance

MSAPMOPS405A

Identify problems in fluid power system

MSAPMOPS406A

Identify problems in electronic control systems

MSAPMOPS401A

Trial new process or product

MSAPMOPS400A

Optimise process/plant area

MSAPMSUP390A Use structured problem solving tools 

PMASUP420B

Minimise environmental impact of process

PMBTECH406A

Diagnose production equipment problems

Cross Sector units 

FDFPPL4001A

Manage people in the work area

FDFPPL4003A

Schedule and manage production

FDFPPL4006A

Manage a work area within budget

FDFPPL4007A

Manage supplier agreements and contracts

FDFPPL4008A

Manage internal audits*

FDFPPL3005A Participate in an audit processes 

FDFOHS2001A Participate in OHS processes 

FDFFS2001A Implement the food safety program and procedures 

MSAENV272A Participate in environmentally sustainable work practices 

BSBINN301A

Promote innovation in a team environment

BSBLED401A

Develop teams and individuals

BSBMGT402A

Implement operational plan

BSBMGT403A

Implement continuous improvement

BSBSMB407A

Manage a small team

MSACMC411A

Lead a competitive manufacturing team

MSACMS400A

Implement a competitive manufacturing system

MSACMS401A

Ensure process improvements are sustained

MSACMT430A

Improve cost factors in work practices

MSACMT432A

Analyse manual handling processes

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

TAEASS401A

Plan assessment activities and processes

TAEASS402A

Assess competence

TAEASS403A

Participate in assessment validation

TAEDES401A

Design and develop learning programs

GROUP D 

FDFOHS2001A

Participate in OHS processes

FDFOP2030A

Operate a process control interface

FDFOP2061A

Use numerical applications in the workplace

FDFOP2063A

Apply quality systems and procedures

FDFPPL3005A

Participate in audit processes

BSBCUS501A

Manage quality customer service

BSBHRM402A

Recruit, select and induct staff

BSBMGT401A

Show leadership in the workplace

BSBRES401A

Analyse and present research information

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

BSBSMB405A

Monitor and manage small business operations

BSBSMB406A

Manage small business finances

BSBWOR401A

Establish effective workplace relationships

BSBWOR402A

Promote team effectiveness

BSBWOR403A

Manage stress in the workplace

BSBWOR404A

Develop work priorities

BSBWRT401A

Write complex documents

MEM15001B

Perform basic statistical quality control

MNMC205A

Conduct local risk assessment

MSACMC410A

Lead change in a manufacturing environment

MSACMC413A

Lead team culture improvement

MSACMS405A

Lead a manufacturing team using a balanced score card approach

MSACMT260A

Use planning software systems in manufacturing

MSACMT261A

Use SCADA systems in manufacturing

MSACMT280A

Undertake root cause analysis

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

MSACMT453A

Use six sigma techniques*

MSACMT452A Apply statistics to processes in manufacturing 

MSACMT460A

Facilitate the use of planning software systems in manufacturing*

MSACMT260A Use planning software systems in manufacturing 

MSACMT461A

Facilitate SCADA systems in a manufacturing team or work area*

MSACMT261A Use SCADA systems in manufacturing 

MSAENV272A

Participate in environmentally sustainable work practices

MSAPMPER201A

Monitor and control work permits

MSAPMPER300B

Issue work permits*

MNMC 205A Conduct local risk assessment 

MSAPMPER400A

Coordinate permit process*

MSAPMPER300B Issue work permits 

MSAPMSUP310A

Contribute to the development of plant documentation

MSAPMSUP390A

Use structured problem solving tools

RTE4914A

Participate in an e-business supply chain

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