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(Senior) QA Specialist

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The company

Our client is a professional Pharmaceutical and Biotechnology organisation, based in Noord-Holland Netherlands. They are a global company and leader in engineered T cell therapy.

Role description

You will work within the Quality team, supporting the new area of cancer immunotherapy. You assist in the development, implementation and maintenance of a quality system. With this you contribute to the commercial marketing of the cell therapy product in the EU.

Responsibilities

- Receipt and disposition of incoming materials
- Batch documentation, release and batch record review
- Preparations for product disposition by QP
- Supervise the EU packaging and shipping process and monitor the product disposal
- Review and approval of deviations, Change Controls and CAPAs
- Handling of product complaints for EU
- Liaise with other manufacturing sites, supply chain, CMO’s, corporate quality and other quality groups to maintain global quality
- Implement and maintain GMP training system in EU
- Support and manage the inspection process

Requirements

- BSc or MSc in biological sciences or related field
- 5+ years of quality or manufacturing experience in a Pharmaceutical, Biotech or Biologics organization
- Working knowledge and ability to apply GMPs in conformance to US and EU standards
- Excellent written and spoken English language skills (Dutch is a plus)
- Quality Assurance, GMPs, Health Authority Regulations and Validation practices/principles
- Excellent MS Office skills
- Experience with and knowledge of Change Control practices, Deviations and CAPA, manufacturing processes, GMP, including GDP, SOPs and quality systems

Other information

Our client is looking for someone who can start as soon as possible. This person needs to be an all-rounder and selfstarter who can operate without guidance and is able to work in a dynamic and diverse team.

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: 48557
Placé par: SIRE Life Sciences®
Posté le: 20-08-2019
Pays: The Netherlands
Région: Noord-Holland
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