Aseptic Consultant

For one of our clients working in the pharmaceutical industry, we are currently looking for an ASEPTIC CONSULTANT

Start: ASAP
Duration: 6 months + extension
Location: South of Brussels

FUNCTION DESCRIPTION:

Mission located within one (sometimes two, depending the workload) unit. Depending on the unit, the mission can slightly change butis always focussed on achieving aseptic & environmental monitoring improvement according to the quality improvement plan defined in eachunit. Three main subjects are part of this quality plan:
- Environmental monitoring
- Media-simulation
- Aseptic practices

It includes daily contact with production, quality assurance and possibly validation.

KEY RESPONSIBILITIES:

The following responsibilities can be requested in the detailed mission:

* Active participation to the plan definition per unit
* Being responsible for risk assessments with the support of a unit team
* Write documents like for exemple rational document (often in English)
* Definition of detailed improvements plan
* Coordination of implementation activities
* Training for staff
* Shop floor presence
* Representation of the unit in specific meetings

PREREQUISITES:

Education :

* University degree: scientific master level or equivalent experience in aseptic production

Knowledge :

* Professional experience: 1 to 10 years of experience in an aseptic biotechnology or pharmaceutical environment.
* Knowledge in aseptic practices
* French and English written and spoken
* Basic knowledge of IT tools (Word, Excel, PowerPoint, Outlook )
* Analytical mind, good partnership, communication & influencing skills, sense of urgency, flexibility and accountability, executive capabilities and in specific cases leadership to manage field project teams.