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QA System Specialist

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The company

Our client is a professional Pharmaceutical organisation, based in Brussels Hoofdstedelijk Gewest Belgium. Our client is a global full-service Contract Development & Manufacturing Organization (CDMO) for the production of APIs, Drug Products, and associated Packaging Services.

Role description

The Quality System Specialist will be working as part of the Quality Assurance Department and ensure that the products are manufactured, stored and packaged in accordance with cGMP.

He / she will also support the development of GMP training packages and, if necessary, delivery of training. Under the direction of the reporting manager, he / she will continuously improve QA and Compliance systems, strengthen quality awareness and investigate quality issues using applicable process improvement and problem solving techniques to assure successful outcomes of Company and external Health Authority inspections.

Responsibilities

• Provide QA support for / Fournir un support QA pour:
- Investigation and closure for the Deviation and the Out Of Specifications / Investigation and cloture des deviations et des OOS
- Change Control initiation and implementation / Initiation et implémentation des Demandes de Changement
- CAPA initiation and implementation / Initiation et Implémentation de CAPA
• Documentation and records review / Revue Documentaire et enregistrements de donnée:
- Procedure, Master Batch Record, Specifications… / Procédure, Master Batch Record, Specifications…
- Batch records and associated documents after production / Dossiers de lot et documents associés après production
- Control Cleaning Records / Vérification des données de nettoyage
- Maintain the calibration program and the monitoring for the facilities up to date / Maintenir le programme de calibration et le monitoring des installations à jour.

Requirements

• Minimum qualifications / Qualifications minimum: Master degree Sciences
• Professionnal experience required / Expérience professionnelle requise: Min.5 years in a QA position/ 5 années dans une fonction QA
Specific skills required / Compétences spécifiques requises:
• Good knowledge of cGMP in a regulated environment (ICH Guidelines) / Bonnes connaissances des cGMP dans un environnement contrôlé (ICH guidelines)
• Excellent accuracy and attention to detail / Excellente précision dans le travail et d’attention au détail
• Excellent interpersonal skills / Excellentes compétence relationnelles
• Working knowledge of MS office packages (Word, Excel, Power Point) and TrackWise® System is in asset / Connaissance de MS office (Word, Excel, Power Point) et du système TranckWise® est un plus.
• Strong problems solving skills, issue resolution and root cause analysis / Forte aptitude à résoudre des problèmes, trouver les solutions et les causes racines
• Highly Flexible and Adaptable. Able to work independently in a fast paced multitasking environment / Grande flexibilité et adptable. Capable de travailler en toute autonomie et dans un environnement multitâche
• Language: French, English knowledges is an asset / Langue: Français, connaissance de l’anglais est un atout.

Other information

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Ewout de Jong.


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SIRE Life Sciences®

Listed by: SIRE Life Sciences®
Listed on: 15-04-2019
Country: Belgium
Region: Brussels Hoofdstedelijk Gewest
Employment: Permanent
Expertise: 3 - 5 years
Location Type: On location
Education: Bachelor
Language: French
Sector: Pharmaceutical
Specialisation: Quality

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Contact

SIRE Life Sciences B.V.

Mondriaan Tower
Amstelplein 52, 25th floor
1096 BC Amsterdam
+31 (0) 20 658 9800

SIRE Life Sciences Belgium BVBA

Science 14 Atrium
14b, Rue de la Science
1040 Bruxelles
+32 (0) 2 588 1277

SIRE Life Sciences Deutschland GmbH

Fünf Höfe
Theatinerstraße 11
80333 München
+49 (0) 89 3803 8966

SIRE Life Sciences UK

702 Howard House Dolphin Square
SW1V3PQ London
+44 7307 179882

SIRE Life Sciences Maastricht

ROOOMS Maastricht
Boschstraat 21
6211 AS Maastricht


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Luzern
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SIRE Staffing

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1096 BC Amsterdam
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