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Quality Systems Manager / Permanent / Pharma / Brussels

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The company

Our client is a professional Pharmaceutical organisation, based in Brussels Hoofdstedelijk Gewest Belgium. Our client is specialised in the development of small molecules for the pharmaceutical industry. They are located all over the world, with 4 different production locations in 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
- Developing and implementing a Quality System based on Business process approach
- 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

- You have preferably a Master in Engineering
- You have 8 years experiences with 3 years in an operational role in a GMP environment
- Very good knowledge of GxP in a regulated environment
- Knowledge of risk assessment / validation (IQ/OQ/PQ) / quality systems
- Strong problems solving skills, issue resolution and root cause analysis
- Highly Flexible and Adaptable
- Knowledge of Quality Software Systems (Trackwise, Lab software, …) is an asset
- You are fluent in French and English

Other information

You have a chance to work in a fast paced environment. There are a lot of growing opportunities within the function and the company

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


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SIRE Life Sciences®

Ref. number: 47450
Listed by: SIRE Life Sciences®
Listed on: 13-05-2019
Country: Belgium
Region: Brussels Hoofdstedelijk Gewest
Employment: Permanent
Expertise: 3 - 5 years
Location Type: On location
Education: Bachelor
Language: French
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 Maastricht

ROOOMS Maastricht
Boschstraat 21
6211 AS Maastricht


SIRE Group GmbH

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6039 Root
Luzern
+41 (0)43 508 1743

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SIRE Staffing

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+31 (0) 85 044 4650

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