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Sr. QA Specialist - GMP

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The company

Our client is a professional organisation, based in Netherlands. .

Role description

In this role you will make sure that that the company is compliant to EU legislation and you will be making the quality processes more efficient.

Responsibilities

-Working with the site validation teams providing guidance in the strategy, planning, delivery and retirement several systems
Reviewing and approving cGMP documents
Approving investigations assuring they are complete, accurate, technically justified with the required documented evidence including risk assessments
Managing, evaluating and approving changes assuring they are compliant
Tracking the overall status of all quality systems
Participating in the development/ revision of company policies/ guidelines/ procedures and implementation in the site;
Preparing and/ or reviewing performance metrics for quality systems

Requirements

Bachelor’s degree a life sciences related field
At least 7 years of experience
Knowledge of regulations in Production, Validation, Quality Assurance/ Control, Quality Systems
Knowledge of and experience with quality and compliance guidelines and manufacturing processes;
Self-starter and independent
Ability to influence co-workers and stakeholders
Fluent in both Dutch and English

Other information

Heb je interesse en wil je meer weten over deze functie, reageer dan door op solliciteer te klikken en contact op te nemen met Greg Silberstein


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SIRE Life Sciences®

Ref. number: 48266
Listed by: SIRE Life Sciences®
Listed on: 17-07-2019
Country: The Netherlands
Employment: Permanent
Expertise: 6 - 10 years
Location Type: On location
Education: Bachelor
Language: Dutch
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