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Quality Assurance Manager

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The company

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

Role description

You will be responsible for ensuring compliance to GxP requirements across different countries in the CEMEA region. You will fulfill a key role in further developing, implementing and optimizing the CEMEA regional Quality System, supporting affiliates and maintaining GMP/ GDP licenses. You will also be responsible for the quality support of third-party contract organizations and service providers

Responsibilities

You will be responsible for operational QA activities including deviations, temperature excursions, CAPAs and changes;
You will provide support in maintaining the Quality Management System and all operating licenses
Provide Quality support to affiliates, including inspection management, maintenance of an adequate Quality Management System, eQMS user support and management of intra-company Quality Agreements;
Perform and participate in internal/external audits;
Support the management of complaints, quality issues and recalls;
Monitor and report Quality KPI’s for the region and support Quality System Management Reviews;
Provide quality support to third parties in the CEMEA region (manufacturing/ packaging facilities, logistic service providers), including qualification/ validation, auditing, product transfer and contract management activities;
Implement local continuous process excellence and improvement activities for the region;
Support new product launches;
Manage local and regional projects.

Requirements

Masters or Ph.D. preferably in life sciences (e.g. Pharmacy, Biology or Chemistry);
3-5 years Pharmaceutical industry experience in various local and/or global Quality and ideally manufacturing or supply chain roles roles;
A deep understanding of Pharmaceutical GxP processes and regulatory requirements in Europe and possibly other regions;
Ability to drive and manage issues, complaints, CAPAs and changes through to satisfactory conclusion;
Experience with building and implementing lean processes in full compliance with regulatory requirements;
Computer literate, the role holder will need to work in standard office software, SAP, eQMS and any other systems necessary to complete the activities required;
Fluent in written and spoken English, additional languages are a plus;
Ability to communicate effectively through verbal and written media;
Ability to interact with personnel of all levels, including customers;
Excellent organizational, interpersonal, influencing and listening skills;
Ability to travel according to business needs

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®

Réf. nombre: 46986
Placé par: SIRE Life Sciences®
Posté le: 11-03-2019
Pays: The Netherlands
Région: Noord-Holland
Emploi: Permanent
Compétence: 3 - 5 années
Type de lieu: Sure place
Éducation: Master
Langue: Anglais
Secteur: Pharmaceutique
Spécialisation: Qualité

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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

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+31 (0) 20 658 9804

SIRE Information Technology

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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

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Amstelplein 52, 25th floor
1096 BC Amsterdam
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SIRE Engineering

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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

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Amstelplein 52, 25th floor
1096 BC Amsterdam
+31 (0) 85 044 4650

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