Responsibilities Include:
Process Definition
- Publishing new and updated standard operating procedures (SOPs) to reflect agreed process changes.
- Publishing new and updated batch records to reflect agreed process and BOM changes.
- Maintaining the bill of material (BOM) for each production output for use across the organization.
- Securing approval for changes to SOPs and batch records from affected stakeholders prior to publishing.
Specification of Equipment
- Defining functional requirements for new equipment to achieve process performance.
- Prescribing criteria and running tests to confirm equipment changes or upgrades.
- Definition of maintenance required to maintain all aspects of process performance.
New Product Launch
- Devising trials for demonstration of production process capability pertaining to new products.
- Analyzing trial data to identify issues and propose improvements.
- Define material specifications, SOPs, and process parameters that are compatible with our goals for Safety, Quality, Delivery and Cost in mass production.
- Production Support
- Determining the root cause of quality issues and working cross-functionally to propose and implement solutions.
- Generating and assessing proposals for process improvement including changes in procedures, equipment, and tools.
- Analyzing production data to identify issues and propose improvements.