Qualification details

FDF40210 - Certificate IV 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Superseded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Is superseded by FBP40518 - Certificate IV in Pharmaceutical ManufacturingUpdated to meet Standards for Training Packages The number of units to achieve the qualification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

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
AHCBUS405A - Participate in an e-business supply chainParticipate in an e-business supply chain Elective
BSBCUS501C - Manage quality customer serviceManage quality customer service Elective
BSBHRM402A - Recruit, select and induct staffRecruit, select and induct staff Elective
BSBINN301A - Promote innovation in a team environmentPromote innovation in a team environment Elective
BSBLED401A - Develop teams and individualsDevelop teams and individuals Elective
BSBMGT401A - Show leadership in the workplaceShow leadership in the workplace Elective
BSBMGT402A - Implement operational planImplement operational plan Elective
BSBMGT403A - Implement continuous improvementImplement continuous improvement Elective
BSBRES401A - Analyse and present research informationAnalyse and present research information Elective
BSBSMB401A - Establish legal and risk management requirements of small businessEstablish legal and risk management requirements of small business Elective
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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

September 2012: Replacement of superseded imported Units.

November 2011: Updates to imported Units, minor edits.

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.

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

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 ualification, candidates may undertake the FDF50210 Diploma of 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 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

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 Good Manufacturing Practice

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

MSAENV472B

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 interrelated processes in a production system

FDFOP3004A

Operate interrelated 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*

FDFPPL3001A Participate in improvement processes

FDFPPL4005A

Establish process capability*

FDFOP2015A Apply principles of statistical process control

FDFOP2061A Use numerical applications in the workplace

FDFTEC4007A Describe and analyse data using mathematical principles

FDFTEC4001A

Determine handling processes for perishable food items

FDFTEC4002A

Manage controlled atmosphere storage

FDFTEC4003A

Control food contamination and spoilage*

FDFFS3001A Monitor the implementation of quality and food safety programs

FDFTEC4004A

Apply basic process engineering principles to food processing*

FDFOP2030A Operate a process control interface

FDFTEC4007A Describe and analyse data using mathematical principles

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*

FDFOP2015A Apply principle of statistical process control

FDFOP2061A Use numerical applications in the workplace

FDFTEC4008A

Apply principles of food packaging

FDFTEC4009A

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

FDFTEC4010A

Manage water treatment processes*

MSAENV272B Participate in environmentally sustainable work practices

FDFTEC4011A

Participate in product recalls*

FDFFS3001A Monitor the implementation of quality and food safety programs

MSS404081A

Undertake proactive maintenance analyses

MSS404082A

Assist in implementing a proactive maintenance strategy

MSS404083A

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*

FDFPPL3003A Support and mentor individuals and groups

FDFPPL4003A

Schedule and manage production

FDFPPL4006A

Manage a work area within budget

FDFPPL4007A

Manage supplier agreements and contracts

FDFPPL4008A

Manage internal audits*

FDFOHS2001A Participate in OHS processes

FDFOP2063A Apply quality systems and procedures

FDFPPL3005A Participate in an audit process

MSAENV272B 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

MSS403001A

Implement competitive systems and practices

MSS403002A

Ensure process improvements are sustained

MSS403011A

Facilitate implementation of competitive systems and practices

MSS403030A

Improve cost factors in work practices

MSS403032A

Analyse manual handling processes

MSS403051A

Mistake proof an operational process

MSS404050A

Undertake process capability improvements*

MSS404052A Apply statistics to operational processes

MSS404052A

Apply statistics to operational processes

TAEASS401B

Plan assessment activities and processes

TAEASS402B

Assess competence

TAEASS403B

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

AHCBUS405A

Participate in an e-business supply chain

BSBCUS501C

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

BSBSMB405B

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

BSBWOR404B

Develop work priorities

BSBWRT401A

Write complex documents

MEM15001B

Perform basic statistical quality control

MSS402060A

Use planning software systems in operations

MSS402061A

Use SCADA systems in operations

MSS402080A

Undertake root cause analysis

MSS403005A

Facilitate use of a Balanced Scorecard for performance improvement

MSS403010A

Facilitate change in an organisation implementing competitive systems and practices

MSS403013A

Lead team culture improvement

MSS403021A

Facilitate a Just in Time system

MSS403023A

Monitor a levelled pull system of operations

MSS403040A

Facilitate and improve implementation in 5S

MSS403041A

Facilitate breakthrough improvements

MSS404053A

Use six sigma techniques*

MSS404052A Apply statistics to operational processes

MSS404060A

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

MSS404061A

Facilitate the use of SCADA systems in a team or work area

MSAENV272B

Participate in environmentally sustainable work practices

MSAPMPER201A

Monitor and control work permits

MSAPMPER300C

Issue work permits*

RIIRIS201B Conduct local risk control

MSAPMPER400A

Coordinate permit process*

MSAPMPER300C Issue work permits*

RIIRIS201B Conduct local risk control

MSAPMSUP310A

Contribute to the development of plant documentation

MSAPMSUP390A

Use structured problem solving tools

RIIRIS201B

Conduct local risk control

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