Apply SOPs when performing work activities in plants

Identify the type of controlled documents required in manufacturing facilities in compliance with CGMPs requirements

Record non- compliance of Good Manufacturing Practices (GMPs) or cleanroom protocols

Report and inform respective parties on any non-compliance with manufacturing or clean room protocols and practices

Explain the importance of abiding by CGMPs to external parties such as vendors

Perform work processes in accordance with CGMPs

Check work processes for compliance with CGMPs

Take corrective actions against non- compliance of Good Manufacturing Practices (GMPs) or cleanroom protocols

Identify improvements that can be made to promote better alignment of processes with CGMPs

Translate CGMPs standards into operating protocols for a department

Establish processes to monitor compliance with CGMPs in a department

Introduce risk control programmes and activities for a department in line with organisational policies

Develop validation strategies to demonstrate processes are fit for intended uses in accordance with CGMPs and other regulatory guidelines

Control and monitor operations in accordance with regulatory guidelines

Review CGMPs deviations

Establish systems and programmes for CGMPs training

Synthesise processes across the design, monitoring, and control of manufacturing practices and align to CGMPs

Establish processes to monitor compliance with CGMPs across the organisation

Build a culture that promotes alignment to CGMPs across the organisation

Lead risk control programmes

Resolve significant deviations with senior quality review teams

Investigate root causes of serious breaches and deviations from CGMPs standards