Quality Officer M/F

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