QA-RA Officer

25-3-2020 brussels
job description

Are you looking for a QA-RA Officer position ? 

Send me your CV at : pierre.martel@cx.ausy.be or call me : 0493 25 21 35

The QA-RA Officer will provide assistance to the QA-RA Manager for the following activities:

Administrative follow-up/supervision of customer complaints about quality issues.

Layout and drafting of various QA-RA documents including organizational procedures, quality manual, internal audit reports

Conducting internal and external audits: planning of audits, routine interview, reports writing

Supervision through the commercial Divisions of the writing and inventory of ISO Work Instructions, supplier evaluation

Supervision and verification of the environmental storage conditions of the products in the warehouse

Insuring fulfilment of all Good Distribution Practices requirements with regard to the distribution of medicinal products

Assistance with mandatory ISO 9001 & 13485 standards pre-audit documentary updates (quality objectives matrix and KPI’s, document management database, process sheets, annual listing of staff trainings, frequency statistics of product complaints, staff competence, list of approved suppliers

Check through the commercial Divisions for exhaustive AFMPS-FAGG authorization/notification of current manufacturers (and getting all necessary CE certificates and declaration of conformity)

Harmonizing the Quality within the company and providing of training to (new) staff regarding mandatory QA-RA subjects


In addition to daily routine QA-RA work and of specific solving of problems:

AFMPS-FAGG medical devices/implants inspections (3 - 4x/year)

Setting up and implementing a QMS documentation software

Support to INAMI-RIZIV reimbursement dossiers

Legislation analysis and implementation of Sunshine Act / Transparency.be requirements

Regulatory watch

Implementing requirements for distributors regarding New European Regulation for medical devices and IVD MD

Support to set up of UDI (Unique Device Identification) requirements within the company

Biocides / SPF-FOD : new legislation understanding and implementation and follow-up of reporting to Authorities of the quantities of product distributed

Maintain contacts between all support departments and commercial divisions in the company



your contribution

(Industrial) Pharmacist (Master, PhD) or Master in Sciences

English: Fluent spoken and written

Dutch and French: working proficiency

Active knowledge of GDP (Good Distribution Practices), ISO 9001 and ISO 13485 standards and qualified for conducting internal audits

3 to 15 years of experience in Quality Assurance Management and/or in Regulatory Affairs in the medical device or pharmaceutical sector

Excellent command of Word, Excel and PowerPoint

High organizational skills, good interpersonal skills, flexibility in tasks and schedules

Sense of responsibility, enthusiasm, diplomacy and determination to learn are a must


what do we offer?

We offer an attractive salary with extra-legal advantages 

summary
function
quality and environment specialist (m/f)
employment type
full time
contract type
immediate permanent employments
reference
CXRSP-89186
your Randstad contact
Pierre Martel
pierre.martel@cx.ausy.be 02 474 60 16
02 474 60 16