Elements and Performance Criteria
- Set scope of project
- Scope the development project
- Specify new product/application requirements
- Analyse existing products (internal and external to workplace) to determine if they meet customer need
- Interpret and apply relevant Acts, regulations and codes of practice
- Prepare product/application development plan
- Obtain approval for development plan from appropriate personnel
- Identify roles and responsibilities of project team members
- Identify quality requirements and quality standards
- Identify and document project timelines taking into account any constraints
- Develop new product formulation
- Evaluate/recommend materials for new product/application
- Calculate required quantities of materials and adjust for properties as appropriate
- Develop/modify products in pilot batch scale in accordance with workplace and regulatory requirements
- Arrange for product evaluation against development brief
- Modify product/application to meet evaluation recommendations
- Edit documentation and issue to appropriate personnel
- Recommend and evaluate packaging for new product/application
- Prepare protocol for stability (shelf) testing of new product/application
- Assist with preparation of quality/ regulatory compliance procedures/ materials
- Prepare product labelling and submit for approval
- Assist in product and analytical method validation
- Implement an effective plant hygiene and asepsis program
- Develop good manufacturing principles for medicinal products (GMP)/principles of good laboratory practice (GLP) protocols for approval by appropriate personnel
- Prepare standard operating procedures (SOPs) for quality and laboratory-related procedures
- Prepare work health and safety (WHS) procedures for the laboratory and manufacturing environment and submit for approval
- Document and report project outcomes
- Complete project reporting requirements