Responsible for the document control of all QA related documents.
- Issue, monitor and archive the documentation of quality assurance records and documents in the Document Management System (review of drafts, batch records and label issuance as outlined in the planning meeting)
- Maintain and organize archiving of controlled documents (e.g. revised SOPs, assembly of batch documentation)
- Handle the processing of change request forms.
- Check that the documents are written in the right template format.
- Arrange approval / signing of controlled documents.
- Assure availability of latest version of controlled documents at recorded locations
- Hand-out and distribution of draft versions, controlled copies and non-controlled copies of controlled documents.
- Assure destruction of returned controlled copies.
- Manage paper and electronic copies of controlled documents in draft and approved version.
- Support for the QA officers on all documentation related activities.
Qualifications and skills:
- Intermediate vocational education.
- Good knowledge of MS Office.
- Knowledge of GMP or Quality Systems is an advantage.
- Good communication skills in English.
- Accuracy, tidiness, self-organized, flexible, attention to detail, team player.