Aseptic Processing Consultant

For one of its clients (pharmaceutical industry) located in Walloon Brabant, Harvey Nash is currently looking for a

ASEPTIC PROCESSING CONSULTANT

Scope of work:

Mission located within one production unit. Depending the production unit, the mission can slightly change but is always focussed on achieving aseptic process & environmental monitoring improvement according to the quality improvement plan defined in each production unit. Four main subjects are part of this quality plan:
- Environmental monitoring
- Media-simulation
- Aseptic practices (including grade A continuity, segregation )
- Product monitoring (if applicable)

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

The following responsibilities can be requested in the detailed mission:

* Participation to the Aseptic part of Quality Improvement plan definition per production unit
* Support to the team for the realization of risk assessments
* Write documents (EM location rational document, WKI, Process mappings, PQ EM and media-sim ) and collaborate to SOPs review
* Define detailed improvements plan
* Coordinate implementation activities
* Prepare training support for Production and QA staffs
* Shop floor presence
* production unit representative in specific meetings

Requirements:

* University degree: scientific master level or equivalent experience in ASEPTIC PRODUCTION
* Professional experience: 1 to 5 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

Tags: aseptic, aseptic process, aspetic processing, aseptic, aseptique

Harvey Nash is a tusted partner of Belgian pharmaceutical companies.