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Quality Systems Manager

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The company

Our client is a professional organisation, based in Waals-Brabant Belgium. .

Role description

The Quality Systems Manager will be part of the Quality Assurance Department and will report into the Head of Quality. Under the direction of the reporting manager, he /she will continuously improve 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

Actively contribute to continuous improvement
o Developing and implementing a Quality System based on Business process approach
o Managing Operational Excellence initiatives
· Manage the requalification plan to maintain the accurate validation / qualification state of facilities and systems.
· Collaboration and participation in projects as Quality Representative for equipment / systems validation / qualification.
· Provide quality guidance for the development of the validation approach.
· Assure requirements traceability throughout the whole project validation file
· Ensure the review/approval of documentation pertinent to equipment /systems validation/ qualification is timely performed to achieve compliance to procedures and regulatory requirements

Requirements

o Engineering degree
o 8 years experiences with 3 years in an operational role in a GMP environment
o Very good knowledge of GxP in a regulated environment
o Knowledge of risk assessment / validation /quality systems
o Excellent accuracy and attention to detail
o Excellent interpersonal skills
o Strong problems solving skills, issue resolution and root cause analysis
o Highly Flexible and Adaptable. Able to work independently in a fast paced multitasking environment
o Working knowledge of computer packages
o Knowledge of Quality Software Systems( Trackwise , Lab software ,…) is an asset
o Language : English , French

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 Greg Silberstein.


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SIRE Life Sciences®

Ref. Nummer: 47450
Veröffentlicht von: SIRE Life Sciences®
Veröffentlicht am: 08-05-2019
Land: Belgium
Region: Waals-Brabant
Beschäftigung: Festanstellung
Sachverstand: 6 - 10 Jahre
Standorttyp: Auf locatie
Bildung: Bachelor
Sprache: Französisch
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 Belgium BVBA

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

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

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SW1V3PQ London
+44 7307 179882

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