Operations Control
Develop and implement effective operational processes demonstrating control, compliance, quality and efficiency.
Assisting any aspect of Operations Control including:
Manufacturing In-House:
Environment / Clean Room Validation / Control
Supplier Evaluation & Selection
Supply, Service & Quality Agreements
Materials / components specification definition & control
Plant / Equipment / Process definition, validation & control (See Verification & Validation)
Completing risk management & PFMEA
Planning manufacture / Assembly
Completing assembly / manufacture / formulation Control
Validating processes including packaging / labelling, sterilisation
Ensuring batch / Lot identification / Traceability/ Release / Records
Contract Manufacturing (including overseas)
As above
Selection & Monitoring
See NCR / CAPA
Preparation of Quality / Technical Agreements
Support Services
- Standard Operating Procedures
- QMS Standards
- Manufacturing Instructions
- Supplier Evaluation and Selection
- Quality Agreements
- Technical Agreements
- Fulfilment Agreements
- Design Transfer
- New Product Introduction
- Manufacturing Specifications
- Process Definition & Control
- Process Validation
- PFMEA
- Environmental Control
- Clean Room (Zone) Validation
- Labelling
- Packaging
- Sterilisation
- Release Control
- Materials Selection
- Materials Stock Control
- Traceability
- Inspection and Testing
- Non-Conforming Product
- Batch Records / Release Control
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