FDF50210 - Diploma of Pharmaceutical Manufacturing
Diploma of Pharmaceutical Manufacturing
This qualification covers the pharmaceutical manufacturing specialisation.
Job Roles The Diploma of Pharmaceutical Manufacturing targets those in senior management, technician or similar roles within pharmaceutical manufacturing industries. It provides extensive skills and knowledge of industry management functions and environment, and the ability to take responsibility for workplace systems.
Pathways into the qualification Pathways for candidates considering this qualification include:
FDF40210 Certificate IV in Pharmaceutical Manufacturing
direct entry
relevant vocational training and/or work experience.
Pathways from the qualification After achieving this qualification, candidates may undertake a relevant Advanced Diploma 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 nine (29) units of competency in accordance with the following rules.
Total units must include a minimum of eleven (11) units coded FDF.
Nine (9) Core units
Twenty (20) Elective units
Elective selection must include:
One (1) Group A elective unit
One (1) Group B elective unit
Six (6) Group C elective units
Five (5) Specialist and Cross Sector units packaged at Certificate IV Group C
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 FDF30210 Certificate III in Pharmaceutical Manufacturing or FDF40210 Certificate IV in Pharmaceutical Manufacturing (maximum of 5)
Units packaged at FDF20210 Certificate II in Pharmaceutical Manufacturing (maximum of 5)
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 3 units), Diploma or Advanced Diploma level (maximum 3 units)
NOTE: Units marked with an asterisk (*) require completion of prerequisite unit/s which is identified under the unit.
Develop the application of enterprise systems in manufacturing
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
Diploma of 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 a range of workplace documentation and records
Select 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 people at all levels of the organisation in a professional manner
Select and apply documentation, communication and interpersonal strategies when dealing with internal and external clients
Select communication methods according to priority, cost and audience needs
Analyse and apply technical information
Analyse data and information to determine implications for work operations
Teamwork
Lead cooperative work relations with people of different ages, gender, race or religion
Provide leadership
Determine performance required to meet internal and external customer needs
Manage organisational processes and provide problem solving support to others
Facilitate team achievements
Problem-solving
Investigate problem causes and implement corrective strategies
Identify and address potential and actual problems associated with work operations or in achieving work outcomes
Identify environmental features, regulations, insurance requirements, legal requirements and other 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
Analyse food safety practices
Initiative and enterprise
Determine information gathering requirements to monitor work processes and procedures
Determine quality and other indicators of work
Identify efficient production processes
Determine and act on situations requiring further information or problem solving
Implement continuous improvement processes
Provide leadership in the workplace
Implement business development processes
Planning and organising
Identify hazards and implement appropriate hazard control measures
Demonstrate time management skills
Determine resource requirements
Determine work timelines and output targets
Optimise work processes
Conduct business planning processes
Self-management
Analyse implications of relevant acts and regulations on work practices
Monitor work operations and identify and act on any quality and performance issues
Manage own time to meet deadlines
Determine workplace procedures and instructions
Conduct work reviews to determine improvement requirements
Learning
Develop learning opportunities
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
Maintain currency of industry skill and knowledge
Technology
Select computer software applications to perform work operations
Work with technology safely and according to workplace standards
Help others use technology efficiently and safely
Ensure readiness and operational efficiency of workplace technology