Quality Improvement Cleaning Consultant

For one of our clients working in the pharmaceutical industry, we are currently looking for Quality Improvement Cleaning Consultant

Start: 1/3/13
Length: 6 months + extension
Location: South of Brussels

DISCIPLINE DESCRIPTION:

* Implement cleaning validation improvements in quality and compliance
* Implement cleaning processes improvements in quality and compliance

KEY RESPONSIBILITES:

*Following the MPF, implement improvements in cleaning practices in alignment with Business and Compliance requirements.
* Assure shopfloor and Cleaning Knowledge within the Manufacturing Unit
* Regularly checking the adequacy of cleaning manipulations during routine production operations providing feedback and implement corrective and preventive actions
* Experiment in new ways of working using new tools and technology and contribute in researching new qualitative-technical solutions for the departments
* Training of good cleaning practices (development, validation, verification)
* Ensure the application of good cleaning practices (in place - in use) and the harmonisation of these practices across the Manufacturing Unit

-Level of influence to be acquired:

* Sufficient technical experience and influence to drive cleaning good practices in his MU (Change Management).
* Complexity and human relations: must operate cross-functionally and be able to work in a Matrix organization. This position requires coordination with Production, Training department, Cleaning QIP team, Center of Excellence, NPI/NPD, Quality Assurance, Planning and Logistics.

INPUTS:

* Local cleaning and cleaning validation SOP's
* Periodic review
* Risk assessments
* Deviations
* Regulatory inspection findings and CAPA's

OUTPUTS:

* Generate trending rapport on Interim Controls
* Prepare and execute requalifications
* Prepare and execute coupon studies
* Calculate acceptance criteria
* Collect all technical data of cleaning systems
* Inventory/Status of RPC cleaning
* Inventory/Status of requalifications (CIP/WM/MC)
* Inventory/Satus of revalidation cleaning
* Inventory of RD's cleaning
* Write justification for equipment without Interim controls
* Deploy Conductivity meters with print
* Deploy TOC on all steps as of purification, and on manual cleaning (cfr USI015)
* Have an updated version of TR for loads/soiling solutions
* Inventory/status of double check clean and dry on manual cleaning

EDUCATION/KNOWLEDGE/EXPERIENCE:

* Minimum Bachelor level in biotechnology
* Bioengineer, Pharmacist, with microbiologist orientation, or equivalent experience on the floor is an advantage
* Previous experience in Cleaning and validation in a Biopharmaceutical Manufacturing environment is essential (1-3 years)

Knowledge:
* Sense of urgency, flexibility and accountability
* Ability to communicate at all levels.
* Ability to work in a high complex Matrix environment.
* Ability to implement/accompany change
* Basic knowledge of IT tools ( Excel, )