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Quality Assurance Specialist

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The company

Our client is a professional organisation, based in Noord-Holland Netherlands. .

Role description

Your main responsibility will be to the administration of the Quality Systemas well as supporting overall Quality Assurance and GxP Compliance.

Responsibilities

Support Quality Systems and documentations (Document control, Deviations, Corrective and Preventative Action (CAPA), Complaints, Change Controls and Quality Agreements);
During inspections or other critical incidents, requests documents and/or actions which need to be delivered and validated by others.
Assist in the good documentation and monitoring of deviations, product complaints and events (process deviations, product technical events, distribution errors, damages and returns) conform current GxP guidelines (Good Distribution Practice, Good Manufacturing Practice);
Support site implementation and maintenance of the controlled QMS document system;
Checks the CAPA and Change Control Requests for completeness and follow up any missing information as necessary;
Maintains the CAPA and Change Control databases and follows up on outstanding CAPA and Change Control plans;
Review and evaluate Global Temperature Excursion events ensuring that a Quality recommendation on product disposition is provided based on review of shipping documentation and event details versus available product stability data;

Requirements

Team player and to be able to work with several disciplines in a multicultural setting;
Bachelor level education or equivalent;
Must be able to work independently and to strict timelines.
Fluency in English;
Demonstrate an understanding of the Quality environment (i.e. through an internship, studies or previous work experience);
Accuracy and an eye for detail;
Ability to prioritize and cope with conflicting pressures and priorities;

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: 47199
Listed by: SIRE Life Sciences®
Listed on: 27-03-2019
Country: The Netherlands
Region: Noord-Holland
Employment: Permanent
Expertise: 0 - 2 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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