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Quality Manager

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The company

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

Role description

Within this exciting company, you will:

• Ensure that (new) regulations are implemented in the company
• All compliance issues including local quality systems in GMP and GDP and Regulatory matters (authorizations, supply…).
• Ensure the quality aspects through participation in cross-organisational projects, reporting systems and meetings (product maintenance, change
controls, deviations, complaints, recall, …)
• QA function with respect to external suppliers and partners directly connected to the manufacturing site (e.g. qualification, audits, quality agreements,
evaluation)
• To promote a good knowledge level in the QA area by setting up a training program for the Quality Unit personnel

Responsibilities

• You will prepare and review the documents linked to the implementation of the Quality Policy and the Quality Management System (SOPs, WI’s…).
• You will implement correct written procedures, in conformity with the internal and international guidelines.
• You will guarantee that a good documentation system is in place.
• You will participate in solving different problems and support for corrective actions in the GxP areas.
• Organisation and performance of Quality Management Review.
• Organisation and performance of self-inspections in GxP relevant areas.
• You will report to the Global Operation Quality: Monthly reporting, inputs to annual report KPIs and Product recall reports.
• QA function with respect to external suppliers such as qualification, audits and quality agreements.
• You will provide help for the establishment of Quality Agreement with the clients partners.
• Act as expert in quality processes tracked in EQMS.
• Participate in the periodic review of the Quality Manual.
• Monthly reporting to Global

Requirements

• Experience as Quality Assurance Officer or Manager
• Fluent in English and Dutch (both verbal and written), French is a plus
• Ability to work easily with digital platforms
• Specific and current knowledge of international rules and guidelines for the pharmaceutical industry, Quality Management Systems, GMP & GDP and
Regulatory Affairs.
• Experience in a pharmaceutical environment is required
• Decision making based on scientific aspect and risk evaluation

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: 47002
Listed by: SIRE Life Sciences®
Listed on: 11-03-2019
Country: Belgium
Region: Vlaams-Brabant
Employment: Freelance
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

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