- Develop a global policy related to validation, process, cleaning, lab methods, software,equipment, moulds and punches in line with international directives FDA, EMEA, ISO. Interacts and gives direction to a global team. Writing and continuously improving global policy procedures and specific instructions per qualification/validation subject that is locally translated into work instructions.
- Develop and maintain the global process control strategy together with global process engineering and relevant process owners.
- Make templates for validation plans, validation and qualification protocols and reports.
- Continuously improve and co- develop the global corporate strategy related to validation and qualification, including the change management process.
- Will involve travel both local and international. Should be open for flexible working hours.
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