FBP40522 - Certificate IV in Pharmaceutical Manufacturing
Qualification Description
This qualification reflects the skills and knowledge for team leaders, supervisors and specialist technical roles within pharmaceutical manufacturing environments. The qualification includes technical skills, problem solving and supervisory skills to operate, monitor and improve the performance of pharmaceutical manufacturing systems, processes and team members.
Work must comply with good manufacturing practice, health and safety and environmental regulations and legislation that apply to the workplace.
No licensing, legislative or certification requirements apply to this qualification at the time of publication.
Entry Requirements
There are no entry requirements for this qualification.
Packaging Rules
To achieve this qualification, competency must be demonstrated in:
BSBLDR414 - Lead team effectiveness
BSBWHS411 - Implement and monitor WHS policies, procedures and programs
FBPPHM4001 - Monitor and maintain Good Manufacturing Practice requirements
FBPPHM4002 - Prepare and review workplace documentation to support Good Manufacturing Practice requirements
FBPPHM4003 - Facilitate contamination control
FBPPHM4005 - Participate in validation of pharmaceutical manufacturing processes
FBPPHM4006 - Respond to non-conformance
FBPPPL3006 - Report on workplace performance
Elective Units
Group A
FBPOPR3019 - Operate and monitor interrelated processes in a production or packaging system
FBPPHM3003 - Work in a controlled environment
FBPPHM3004 - Clean and sanitise facilities and equipment
FBPPHM3021 - Operate a pharmaceutical production process
FBPPHM4004 - Participate in change control procedures
FBPPPL4002 - Plan and coordinate production equipment maintenance
FBPTEC4007 - Describe and analyse data using mathematical principles
FBPTEC4011*- Establish process capability
MSMOPS400 - Optimise process/plant area
MSMSUP406 - Identify faults in electronic control
MSMWHS401 - Assess risk
MSS403011 - Facilitate implementation of competitive systems and practices
MSS403032 - Analyse manual handling processes
MSS403085 - Ensure process improvements are sustained
MSS403087 - Mistake proof an operational process
MSS404054 - Apply statistics to operational processes
MSS404061 - Facilitate the use of SCADA systems in a team or work area
MSS404084 - Undertake process capability improvements
MSS404086 - Assist in implementing a proactive maintenance strategy
PMBTECH406E - Diagnose production equipment problems
Group B
BSBHRM413 - Support the learning and development of teams and individuals
BSBHRM415 - Coordinate recruitment and onboarding
BSBINS401 - Analyse and present research information
BSBLDR411 - Demonstrate leadership in the workplace
BSBLDR413 - Lead effective workplace relationships
BSBOPS402 - Coordinate business operational plans
BSBPEF401 - Manage personal health and wellbeing
BSBPEF402 - Develop personal work priorities
BSBSTR401 - Promote innovation in team environments
BSBSTR402 - Implement continuous improvement
FBPOPR2069 - Use numerical applications in the workplace
FBPOPR4001 - Apply principles of statistical process control
FBPPPL3005 - Participate in an audit process
MSL922001 - Record and present data
MSMPER300*- Issue work permits
MSMSUP390 - Use structured problem-solving tools
MSMWHS201 - Conduct hazard analysis
MSS402080 - Undertake root cause analysis
MSS402083 - Use planning software systems in operations
MSS403010 - Facilitate change in an organisation implementing competitive systems and practices
MSS403021 - Facilitate a Just in Time system
MSS403023 - Monitor a levelled pull system of operations
MSS403040 - Facilitate and improve implementation of 5S
MSS404053 - Use DMAIC techniques
MSS403054 - Facilitate breakthrough improvements
MSS404060 - Facilitate the use of planning software systems in a work area or team
TAEASS402 - Assess competence
TAEASS403 - Participate in assessment validation
TAEDEL301 - Provide work skill instruction
Prerequisite requirements
This qualification reflects the skills and knowledge for team leaders, supervisors and specialist technical roles within pharmaceutical manufacturing environments. The qualification includes technical skills, problem solving and supervisory skills to operate, monitor and improve the performance of pharmaceutical manufacturing systems, processes and team members.
Work must comply with good manufacturing practice, health and safety and environmental regulations and legislation that apply to the workplace.
No licensing, legislative or certification requirements apply to this qualification at the time of publication.
Entry Requirements
There are no entry requirements for this qualification.
Packaging Rules
To achieve this qualification, competency must be demonstrated in:
- 16 units of competency:
- 8 core units, plus
- 8 elective units.
- 4 must be from group A
- 4 from the remaining units listed in groups A or B, or any currently endorsed Training Package or accredited course packaged at Certificate III, Certificate IV or Diploma, with no more than 2 units packaged at Certificate III or Diploma.
BSBLDR414 - Lead team effectiveness
BSBWHS411 - Implement and monitor WHS policies, procedures and programs
FBPPHM4001 - Monitor and maintain Good Manufacturing Practice requirements
FBPPHM4002 - Prepare and review workplace documentation to support Good Manufacturing Practice requirements
FBPPHM4003 - Facilitate contamination control
FBPPHM4005 - Participate in validation of pharmaceutical manufacturing processes
FBPPHM4006 - Respond to non-conformance
FBPPPL3006 - Report on workplace performance
Elective Units
Group A
FBPOPR3019 - Operate and monitor interrelated processes in a production or packaging system
FBPPHM3003 - Work in a controlled environment
FBPPHM3004 - Clean and sanitise facilities and equipment
FBPPHM3021 - Operate a pharmaceutical production process
FBPPHM4004 - Participate in change control procedures
FBPPPL4002 - Plan and coordinate production equipment maintenance
FBPTEC4007 - Describe and analyse data using mathematical principles
FBPTEC4011*- Establish process capability
MSMOPS400 - Optimise process/plant area
MSMSUP406 - Identify faults in electronic control
MSMWHS401 - Assess risk
MSS403011 - Facilitate implementation of competitive systems and practices
MSS403032 - Analyse manual handling processes
MSS403085 - Ensure process improvements are sustained
MSS403087 - Mistake proof an operational process
MSS404054 - Apply statistics to operational processes
MSS404061 - Facilitate the use of SCADA systems in a team or work area
MSS404084 - Undertake process capability improvements
MSS404086 - Assist in implementing a proactive maintenance strategy
PMBTECH406E - Diagnose production equipment problems
Group B
BSBHRM413 - Support the learning and development of teams and individuals
BSBHRM415 - Coordinate recruitment and onboarding
BSBINS401 - Analyse and present research information
BSBLDR411 - Demonstrate leadership in the workplace
BSBLDR413 - Lead effective workplace relationships
BSBOPS402 - Coordinate business operational plans
BSBPEF401 - Manage personal health and wellbeing
BSBPEF402 - Develop personal work priorities
BSBSTR401 - Promote innovation in team environments
BSBSTR402 - Implement continuous improvement
FBPOPR2069 - Use numerical applications in the workplace
FBPOPR4001 - Apply principles of statistical process control
FBPPPL3005 - Participate in an audit process
MSL922001 - Record and present data
MSMPER300*- Issue work permits
MSMSUP390 - Use structured problem-solving tools
MSMWHS201 - Conduct hazard analysis
MSS402080 - Undertake root cause analysis
MSS402083 - Use planning software systems in operations
MSS403010 - Facilitate change in an organisation implementing competitive systems and practices
MSS403021 - Facilitate a Just in Time system
MSS403023 - Monitor a levelled pull system of operations
MSS403040 - Facilitate and improve implementation of 5S
MSS404053 - Use DMAIC techniques
MSS403054 - Facilitate breakthrough improvements
MSS404060 - Facilitate the use of planning software systems in a work area or team
TAEASS402 - Assess competence
TAEASS403 - Participate in assessment validation
TAEDEL301 - Provide work skill instruction
Prerequisite requirements
Unit of competency |
Prerequisite requirement |
FBPTEC4011 Establish process capability |
FBPTEC4007 Describe and analyse data using mathematical principles |
MSMPER300 Issue work permits |
MSMWHS201 Conduct hazard analysis |
Why invest with us?
We have been providing quality training materials for the VET Sector for over twenty years. All of our materials come to you in an electronic format by USB or download and it includes the Candidate Learning Guide, Assessment Tool, Trainer Marking Guide, Competency Mapping Tool, PowerPoint's, and any relevant readings.
Our format enables you to contextualise the material for your Organisations logo (the licence you receive enables this). The resources we know are flexible enough for any group of Students.
Also as the versions change as they invariably do, you will receive the updates at no extra cost to your Organisation.
The investment for these resources is based on the following factors;
We have been providing quality training materials for the VET Sector for over twenty years. All of our materials come to you in an electronic format by USB or download and it includes the Candidate Learning Guide, Assessment Tool, Trainer Marking Guide, Competency Mapping Tool, PowerPoint's, and any relevant readings.
Our format enables you to contextualise the material for your Organisations logo (the licence you receive enables this). The resources we know are flexible enough for any group of Students.
Also as the versions change as they invariably do, you will receive the updates at no extra cost to your Organisation.
The investment for these resources is based on the following factors;
- The resources are able to be contextualised and replicated as you see fit. In other words the licence allows you to reprint and badge and remove and add materials to your specifications – if you feel it is necessary.
- Any additions that we do will be sent to you automatically as they are developed.
- You will receive all the compulsory units as well all the electives required for the course.
- These resources offer the breadth, depth and complexity of knowledge and competencies covering selecting, adapting and transferring skills and knowledge to new environments. Our resources provide you with the technical advice and early leadership skills for problem resolution. Such skills can be applied across a broad range of roles, and in a variety of contexts.
FBP40522 - Certificate IV in Pharmaceutical Manufacturing
FBP40522 - Certificate IV in Pharmaceutical Manufacturing
BSBHRM415 - Coordinate recruitment and onboarding
A$590.62
A$590.62
BSBINS401 - Analyse and present research information
A$590.62
A$590.62
BSBLDR411 - Demonstrate leadership in the workplace
A$590.62
A$590.62
BSBLDR413 - Lead effective workplace relationships
A$590.62
A$590.62
BSBLDR414 - Lead team effectiveness
A$590.62
A$590.62