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QA Specialist Validation // Noord-Brabant // Pharmaceutical

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The company

Our client is a professional organisation, based in Noord-Brabant Netherlands. This client is focused on the secondary packaging, the labeling and the distribution of medicines internationally.

Role description

In this position you will be the liaison between the Quality Assurance team and the Engineering team. Therefore we are looking for someone with a strong knowledge of both technic and quality. Your responsibility is to ensure new equipment is introduced within manufacturing conforming the quality guidelines.

Responsibilities

• Agree on the validation strategy and provide guidance regarding design, characterization and validation for equipment
• Assure agreed validation strategy is properly documented and aligned with procedural and regulatory requirements
• Provide support to Plant QA regarding equipment or information system related production issues.
• Provide quality engineering support to establish appropriate sampling plans and acceptance criteria;
• Project team member to develop efficient quality processes and translate them in standard operating procedures;
• Perform final review of technical change controls, confirming assessments of different stakeholders are complete

Requirements

• Master degree in engineering or pharma;
• At least 5 years of professional experience within a GMP environment;
• Relevant experience with equipment and automation validation;
• Knowledge of the Quality Assurance principles;
• Able to work on a wide variety of projects simultaneously;
• Able to work in a changing environment;
• Fluent in English

Other information

Do you have the right experience and knowledge to perform this job? Let me know!

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


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SIRE Life Sciences®

Ref. Nummer: 47999
Veröffentlicht von: SIRE Life Sciences®
Veröffentlicht am: 19-07-2019
Land: The Netherlands
Region: Noord-Brabant
Beschäftigung: Festanstellung
Sachverstand: 3 - 5 Jahre
Standorttyp: Auf locatie
Bildung: Master
Sprache: Englisch
Sektor: Pharmazie
Spezialisierung: Qualität

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Kontakt

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