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QA Specialist

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The company

Our client is a professional Pharmaceutical and Biotechnology organisation, based in Noord-Brabant Netherlands. They are committed to unlock the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics.

Role description

The QA Specialist will be required to understand a wide range of quality related competencies while providing high complexity tactical support to Site Leads across multiple Quality Systems and Processes.

Responsibilities

- Manage and own NC records, CAPA, Change Control, Quality records, batch disposition and release activities
- Provide tactical information to the networks (metrics to management, data
analysis, trending, periodic monitoring, APR)
- Riskmanagement
- Training on required Quality Systems (NCMS, CCMS, LIMS, SAP and Complaints)
- Improvement initiatives within the Regional work cell and the wider organisation
- Manage Regional Work Cell activities including Visual management, level loading, capacity & capability management

Requirements

- BSc or MSc in biological sciences or related field
- 4+ years of quality or manufacturing experience in a Pharmaceutical or Biotech industry
- GMP experience
- Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes)
- Yellow or Green belt
- English communication skills (Dutch is a plus)

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 Bram Reulen.


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SIRE Life Sciences®

Réf. nombre: 48556
Placé par: SIRE Life Sciences®
Posté le: 20-08-2019
Pays: The Netherlands
Région: Noord-Brabant
Emploi: Free-lance
Compétence: 3 - 5 années
Type de lieu: Sure place
Éducation: Bachelor
Langue: Anglais
Secteur: Pharmaceutique
Spécialisation: Qualité

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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 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 Staffing Solutions B.V.

Keizersgracht 440A
1016 GD Amsterdam
+31 (0) 20 658 9804