As part of a site wide modernization program, the resource will report and provide support to the local program lead. He/She will be responsible for the program documentation including GxP documentation of activities linked to the program.
This includes automation systems, computer systems and equipment's.
All of this in accordance with our company standard processes and compliance rules.
He/she is responsible for:
- Computer System Validation;
- Automation System Validation and qualification;
- Equipment qualification;
- System LifeCycle documentation;
- SOP update;
- Validation of Microsoft Excel workbook following GMP standards in place within our company; Standard meeting which he/she will participate to or organize:
- Weekly project meeting;
- Necessary meeting to succeed in the above responsibilities;
- Pharmaceutical GxP knowledge and experience
- Computer System Validation experience
- Work independently and in team
- Speak and write in Dutch and English
- Knowledge of TrackWise QMS is a plus but not mandatory
- Work from home is not an option
- Working experience: 5 years or more
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