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The company

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

Role description

As Qualified Person you’ll be joining a diverse team and will be working together focusing on saving lives

Responsibilities

Disposition and involve in issue resolution related to manufacturing and testing of vectors and final product to EU destination.
Support site QA head in the implementation of Supplier Quality oversight program in EU. QP must be involved in all critical suppliers, including contract manufacturers and contract test laboratories.
Ensure that the marketing Authorization and Manufacturing Authorization or IMP Authorization requirements for the products have been met for the patient batch concerned.
Support site QA head in setting up a robust Quality Management System
Review all submissions (CMC) to regulatory authorities concerning the product (IMP/MP).
and maintenance of the Pharmacovigilance system in EU
Support inspection readiness plans

Requirements

Registered QP in The Netherlands, experienced in the disposition of biologic products for clinical and /or commercial use
Minimum of 3 years’ progressive quality or manufacturing experience in a pharmaceutical, biotech, or biologics operation
Experience auditing CMOs
Experience with direct European Health authority inspections and interactions
Experience writing, evaluating and closing investigations, CAPAs and change control records.
In-depth knowledge of and ability to apply GMP
Proficient in MS Word, Excel, and Power Point

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: 47590
Listed by: SIRE Life Sciences®
Listed on: 06-05-2019
Country: The Netherlands
Employment: Permanent
Expertise: 3 - 5 years
Location Type: On location
Education: Master
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