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Summary

experience:

- deviation and complaint handling
- corrective and preventive actions
- change controls
- internal and external Auditing of manufacturers (api / fp), laboratories and warehouses
- review and approval of batch related documents: bmr/bpr, Validation protocols, ...
- standard operating procedures
- batch release
- technical agreements

characteristics:

- enthusiast
- eager to learn
- teamplayer
- well organized

Personality

Self Assessment :
Problem solvingOptimismAttention to detailCritical thinking

Knowledge

Self Assessment :
SOPQuality Assurance (QA)EMAEnglishFDAGood Manufacturing Practice (GMP)ICH GCP guidelinesKnowledge of the drug development processMicrosoft ExcelMicrosoft OfficePharmaceutical IndustryUnderstand how results translate to practiceWriting Study Procedures and SOPs

Education

  • Advanced Master in Industrial Pharmacist from Ghent University in 2012

Area / Region

Eeklo, België

Others

Driving License
  • Yes

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