Elements and Performance Criteria
- Empower team members to identify GMP requirements
- Ensure personal protective equipment and contamination prevention clothing used by team members is serviceable and fitted correctly according to work health and safety requirements
- Ensure GMP requirements and workplace procedures are available
- Identify and address training needs according to team member's level of responsibility
- Provide training and coaching to support individuals and groups to implement GMP requirements and related workplace procedures
- Demonstrate personal hygiene to others to support implementation of GMP requirements and workplace procedures
- Monitor and control resource allocation according to workplace procedures and GMP requirements
- Ensure GMP control measures used in the work area are identifiable by workers
- Monitor personal hygiene and conduct of team members
- Ensure personal hygiene of work team meets GMP requirements
- Prepare, use, store and dispose of personal protective equipment and contamination prevention clothing according to GMP requirements and workplace procedures
- Ensure personal movements within workplace comply with area entry and exit procedures
- Monitor implementation of GMP requirements
- Clearly define, document and follow GMP requirements in work area
- Conduct a root cause analysis (RCA) as part of a cross-functional team and report non-compliance(s) from workplace procedures
- Identify and report GMP non-conformance(s) and signs of unacceptable plant or equipment condition
- Put in place quality approved corrective action or preventative action (CAPA)
- Record information according to workplace reporting procedures and to meet GMP requirements
- Ensure team members maintain work area according to workplace cleaning standards
- Maintain and facilitate continuous improvement of GMP
- Identify, report and correct processes or conditions which could result in GMP non-conformance according to individual level of responsibility
- Promptly resolve matters relating to GMP or refer them to appropriate personnel
- Monitor effectiveness of CAPA and control measures according to level of responsibility
- Advise others in the work area of GMP matters relevant to their work role
- Maintain workplace records and documents according to workplace procedures and GMP requirements