Modification History
|
Release |
Comments |
|
Release 1 |
This version released with FBP Food, Beverage and Pharmaceutical Training Package Version 2.0. |
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 occupational 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.
Elective units must ensure the integrity of the qualifications’ Australian Qualification Framework (AQF) alignment and contribute to a valid, industry-supported vocational outcome. The electives are to be chosen as follows:
- 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.
Core Units
|
BSBSMB407 |
Manage a small team |
|
BSBWHS401 |
Implement and monitor WHS policies, procedures and programs to meet legislative requirements |
|
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
|
FBPOPR3005 |
Operate interrelated processes in a production system |
|
FBPOPR3006 |
Operate interrelated processes in a packaging system |
|
FBPPHM3002 |
Operate a pharmaceutical production process |
|
FBPPHM3003 |
Work in a controlled environment |
|
FBPPHM3004 |
Clean and sanitise facilities and equipment |
|
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 |
|
MSS404052 |
Apply statistics to operational processes |
|
MSS404061 |
Facilitate the use of SCADA systems in a team or work area |
|
MSS404082 |
Assist in implementing a proactive maintenance strategy |
|
MSS404084 |
Undertake process capability improvements |
|
PMBTECH406 |
Diagnose production equipment problems |
Group B
|
BSBHRM405 |
Support the recruitment, selection and induction of staff |
|
BSBINN301 |
Promote innovation in a team environment |
|
BSBLDR402 |
Lead effective workplace relationships |
|
BSBLDR403 |
Lead team effectiveness |
|
BSBLED401 |
Develop teams and individuals |
|
BSBMGT401 |
Show leadership in the workplace |
|
BSBMGT402 |
Implement operational plan |
|
BSBMGT403 |
Implement continuous improvement |
|
BSBRES411 |
Analyse and present research information |
|
BSBWOR403 |
Manage stress in the workplace |
|
BSBWOR404 |
Develop work priorities |
|
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 in 5S |
|
MSS403041 |
Facilitate breakthrough improvements |
|
MSS404053 |
Use DMAIC techniques |
|
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 |
Qualification Mapping Information
|
Code and title current version |
Code and title previous version |
Comments |
Equivalence status |
|
FBP40518 Certificate IV in Pharmaceutical Manufacturing |
FDF40210 Certificate IV in Pharmaceutical Manufacturing |
Updated 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 |
No equivalent qualification |
Links
Companion Volume Implementation Guides are found in VETNet: - https://vetnet.gov.au/Pages/TrainingDocs.aspx?q=78b15323-cd38-483e-aad7-1159b570a5c4
