Quality Officer M/F
V.I.E. BELGIUM Design / Civil engineering / Industrial engineering
Job description
Informations générales
Référence
2017-3874
Date de parution
10/04/2018
Branche
Pharmaceutique
Société
PIERRE FABRE SANTE BENELUX S A
Description du poste
Intitulé du poste
Quality Officer M/F
Contrat
VIE
Durée du contrat
12
Taux d'activité
Temps plein
Mission
Within the Belgian subsidiary and reporting to the QRVI Manager and the Local Safety Officer, you contribute to the daily missions in quality assurance and regulatory affairs.
To the end, you will participate in :
** Quality assurance ** :
- Participate to the development and maintenance of a Quality Management System according GxP's and Corporate requirements in accordance with the legislation in force;
- The QMS will have to take into account the legal local requirements laid down by the files submission, the production, the marketing, the sales … and the Corporate requirements;
- Participate to the Quality Complaints Handling , Product Recall according to Corporate Sop and global Policy;
- Participate to the Change Control System Management / Technical Regulatory Compliance;
- In case of local (including repackaging) production, assure that products manufactured by the affiliate always comply with the registered files;
- Participate to the organization of internal audits of the affiliate, in order to evaluate the compliance to local regulatory requirements, and to headquarters requirements;
- Inform Corporate QA about inspections, participate to inspection on the site(s), and provide the adequate corrective / preventive actions to Inspectorates (FDA, EMA, Anvisa,… others) in agreement with Corporate QA;
- Involved in writing of all Quality Agreements signed by the affiliate in case of subcontracting regulated activities;
- Assure a technological and regulatory watch about quality ;
- Participate to reporting of his/her activity through metrics (given by Corporate QA) : Complaints, Deviations…;
Profil
- Scientific Master Degree (Pharmacist ie) or equivalent (Scientific Degree/Life sciences)
- Minimum of 1 year experience in pharmaceutical and/or cosmetic industry in Quality Assurance Department
- Organizational and administrative capacity
- Rigorous, team Spirit, result oriented, auto-organization and process controlling
- Analytical ability
- Fluent in French and English
- Dutch is a plus
Localisation du poste
Localisation du poste
Europe, Belgique
Lieu de travail
Bruxelles
Critères candidat
Niveau d'études minimum requis
Bac +4 / Bac +5
Niveau d'expérience minimum requis
1 an ou plus
Demandeur
Date de prise de fonction souhaitée
01/07/2018