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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

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.

As member of the Quality department :
o Evaluation / Approval of deviation and support to related investigations
o Operate the change control system (risk assessment, assessment of validation / qualification needs ; follow up )
o Operate the CAPA system
o Work with relevant departments to ensure timely closure of quality actions / findings
o Perform inspections/internal audits and provide quality oversight for the inspection/ audit program
o Collaborate with operations to resolve compliance matters

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. number: 44944
Listed by: SIRE Life Sciences®
Listed on: 15-04-2019
Country: Belgium
Region: Waals-Brabant
Employment: Permanent
Expertise: 6 - 10 years
Location Type: On location
Education: Bachelor
Language: English
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


SIRE Group GmbH

Platz 3
6039 Root
Luzern
+41 (0)43 508 1743

SIRE Staffing Solutions

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

SIRE Information Technology

Calypso Building
Kruisplein 480
3012 CC Rotterdam
+31 (0) 10 316 1066

SIRE Healthcare

Mondriaan Tower
Amstelplein 52, 25th floor
1096 BC Amsterdam
+31 (0) 85 044 4640

SIRE Finance

Mondriaan Tower
Amstelplein 52, 25th floor
1096 BC Amsterdam
+31 (0) 85 044 4630

SIRE Engineering

Calypso Building
Kruisplein 480
3012 CC Rotterdam
+31 (0) 10 316 6626

SIRE Human Resources

Mondriaan Tower
Amstelplein 52, 25th floor
1096 BC Amsterdam
+31 (0) 85 044 4620

SIRE Staffing

Mondriaan Tower
Amstelplein 52, 25th floor
1096 BC Amsterdam
+31 (0) 85 044 4650