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Senior Manager Quality - Temporary - 3 months (with a chance of extension) - fulltime

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The company

Our client is a professional Pharmaceutical and Chemicals organisation, based in Noord-Holland Netherlands. They are a research-driven pharmaceutical company and focus to bring the highest value on patient care.

Role description

You will provide support to the Quality Systems and GMDP Compliance functions within the Quality department of Europe and aid in the development of a Global Quality culture and way of working within the company.

Responsibilities

- GMDP Compliance Support
- External and Internal auditing of GxP Vendors within Europe
- Review and approval of internal and external GMDP Deviations and CAPAs
- Providing QA advice to other functions (Commercial, Regulatory CMC, IMP/Clinical supplies, Supply Chain,Generation, review and approval of GMDP, SOPs, Change Controls, CAPAs, Deviation Investigations, OOS/OOE/OOT investigations, Quality/Technical Agreements, Internal Quality Agreements)
- Supporting global projects (eQMS, eDMS, eLMS)
- Quality Systems Support (Implementing, maintaining and improving GxP Quality Sustems for Europe
- Drive improvements to the training systems and promote training compliance
- Establishment and monitoring of key metrics for Quality Systems
- Ensuring management oversight of the performance of Quality Systems for Europe
- Driving compliance within our GxP Quality Systems through effective monitoring and communication

Requirements

- Degree in Chemistry or related area
- Background in Chemistry / small molecule GMP is required (technical small molecule GMP input will be required)
- 5+ years of QA experience in the pharmaceutical industry
- MS Office
- Fluency in English
- Experience in GxP Quality Systems and GMDP Compliance

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 Bram Reulen.


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SIRE Life Sciences®

Ref. number: 48335
Listed by: SIRE Life Sciences®
Listed on: 22-07-2019
Country: The Netherlands
Region: Noord-Holland
Employment: Freelance
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


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