C.A.F.-D.C.F. - Central Fractionation Unit of the Red Cross
Neder-Over-Heembeek, Belgium
The Central fractionation Unit of the Red Cross (C.A.F.-D.C.F.) located in Neder-Over-Heembeek specializes in blood plasma fractionation and the preparation of stable plasma derivatives.
Out of more than 180 000 liters of Belgian plasma per year, drawn from volunteer and unpaid donors and out of more than 1 000 000 liters of foreign plasma per year, proteins are isolated through the high technology process of fractionation.
C.A.F.-D.C.F is the cornerstone for medicines derived from human origin. These medicinal products are used primarily for transplantations, treatment of clotting problems and the treatment of heavy burns.
C.A.F.-D.C.F. plans on expanding the worldwide processing of plasma, in collaboration with our partners to increase the volume of the plasma to be treated.
Description of the profile
Reports to the Supervisor QA.
Objectives:
As a Quality Engineer you guarantee the quality at CAF-DCF by following up and insure that all operations on all levels are made in accordance with the applied cGMP quality systems. You will contribute to the fact that the quality of all pharmaceutical products of CAF-DCF satisfy the European and American guidelines of cGMP.
- As a Quality Engineer your focus will be on validation activities. Your primary focus will be on the follow up of validation protocols and you will make reports concerning cleaning and process validation. You take care of the review of quality protocols and of reports concerning the qualification of equipment, of utilities such as water systems and HVAC systems and of IT validation.
Main responsibilities and areas of result:
1. Guarantee the quality by following up and insure that processes and operations are made in accordance to the applied cGMP quality systems:
- You will evaluate written events (deviations, OOS/OOL);
- You will follow up written documents like procedures, protocols and reports concerning quality systems of other departments;
- You will revise and authorize these procedures, protocols and reports;
- You will manage the batch records and lab records.
2. Participate at different projects concerning risk-analyses, qualification and validation:
- You will take care of the execution of the risk-analyses and you will determine corrective and preventive actions (CAPA’s);
- You will follow up changes through Change Control;
- You will follow up initial and routine validations and qualifications;
- You will participate or guide quality related projects.
3. Inform, call attention to and train CAF-DCF employees:
- You will participate in the securing the level of quality and you will work on a continuous improvement of the quality;
- You will be responsible for informing the colleagues concerning quality, pharmaceutical legislation and rules;
- You will stimulate employees to handle in compliance with pharmaceutical rules.
Profile:
- Educational level: Bachelor/master degree (preference: chemistry, industrial pharmacy, biotechnology, …);
- Minimum 2 years of experience within a similar role within the pharmaceutical or food sector;
- Familiar with working in a regulated environment, GMP guidelines (Good Manufacturing Practices) and SOP’s (Standard Operating Procedures);
- Familiar with MS Office, experience in SAP/TRACKWISE is an advantage;
- Fluent in Dutch and French, with a good working knowledge of English;
- Analytical and problem-solving;
- Result oriented and decisive;
- Client oriented, persuasive, communicative and a teamplayer.
Offer:
CAF-DCF offers long term prospect to work in an international high technology environment. CAF-DCF invests in comprehensive on-the-job trainings. We offer a competitive salary, group- and hospitalization insurances, meal vouchers and eco-checks. We offer a flexible arrangement for annual leave with extra days off.
Interested? Send us your motivational letter and CV online or at HR-RH-Info@caf-dcf-redcross.be.