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QA Manager Pharmaceuticals

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The company

Our client is a professional organisation, based in Noord-Holland Netherlands. With a wide range of generic medicines on the market such as cardiovascular, dermatological, antibiotics, antihistamines, antidepressants and a range of inhalations products. This company has all disciplines in-house for product development. With a dedicated professional team, the highest standards are pursued in the areas of Registration, Quality, Pharmacological and Supply Chain.

Role description

In this role you are responsible for the QA department, including the operational QA tasks. Oversee manufacturing processes and manufacturing personnel regarding Quality. You will train, lead, and coach teams whilst developing and implement Quality floor processes. Receipt and disposition of incoming materials. Review batch-related documentation, and ensures resolution of issues to release product. Oversee the packaging and shipping process for the EU.

Responsibilities

- Ensure Deviations are initiated, investigated and resolved.
- Ensures CAPAs are initiated and resolved.
- Batch record review.
- Intake of product complaints for EU and/or related investigations.
- Liaise with QP and other quality groups to develop, implement and maintain global quality systems as well as site-specific quality systems (GMP) in the EU.
- Support inspection readiness plans and interact with regulatory agencies during inspections as needed.

Requirements

- Bachelor’s degree or Master's in the life sciences or related field.
- Minimum of 3 years’ QA experience in a pharmaceutical
- Minimum of 3 years of management/leadership experience
- Working knowledge of GMPs in conformance to EU standards
- Ability to train, manage, and develop teams
- Excellent verbal and written communication skills
- Professional working knowledge of English and preferably Dutch

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 Turlough White.


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SIRE Life Sciences®

Listed by: SIRE Life Sciences®
Listed on: 03-12-2019
Country: The Netherlands
Region: Noord-Holland
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 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 Staffing Solutions B.V.

Keizersgracht 440A
1016 GD Amsterdam
+31 (0) 20 658 9804

SIRE Life Sciences Consultancy B.V.

Wetenschapsstraat 14B
1040 Bruxelles
+32 (0) 2 588 1277