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Quality assurance for local customizations
Project duration: 3 months
Brief description
The aim is to design and create a local customization standard operation procedure. This SOP only deals with local adaptations or modifications made in the corresponding region, i.e. activities with and without regulatory relevance, such as: (re)-labeling, (re)-packaging, bundling and dismantling.
Subject description
Our customer's quality department, a global market leader in the field of blood glucose monitoring equipment and insulin pumps, needs help to ensure that the national organizations also comply with global process requirements after restructuring, e.g. local customization. Local customization refers to local adaptations or modifications to the original product packaging made for a variety of reasons, e.g. to comply with local regulatory requirements or for marketing purposes. The documents are used in the global, internal and external audits (ISO certifications), provided that the processes are part of the quality management system of the national organization in question.
IT project data
- Industries pharmaceutical industry
- Specialist tasks ISO 9000 certification, project planning, QM in the project, quality management, Total Quality Management
- DP tasks concept
- System environments Internet/Intranet, organizational consulting
- Procedure model iterative procedure
Project period05.04.2016 - 06.07.2016
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