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QA Manager

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The company

Our client is a professional organisation, based in Netherlands. The company is at an very exciting phase, with a lot of expansion within Europe

Role description

In this very exciting role you will become responsible for a very exciting phase within the company. Your 2 major responsibilities will consist out of developing in-country Quality Management Systems as a sub part of the Global Quality Management System.
Also, you will require license infrastructures to enable local commercial operations.

You will be traveling up to 30% to make sure that the sites are on track.

Responsibilities

-You will be part of a team which will develop a quality assurance program in Europe. This means you will get an active role within training and audits, you
will require and maintain licences for distribution within Europe.
-You will review SOPS, investigations, specifications, validation reports, manufacturing records and analytical reports
-Provide quality oversight, which includes performing audits and establishing quality agreements with our service providers
-You will be overseeing product issues in Europe, including recalls and complaints
-Establishing an efficient workflow to ensure operational excellence, while making sure that all quality operations are in compliance throughout a QMS
-Prepare, review and approve reports both internally and externally required by regulatory agencies and customers
-Provide training and support to staff members to develop auditing resources
-Lead in operational in excellence initiatives companywide, in order to obtain overall improvement
-Collaborate with other departments to increase the effectiveness of the quality department
-Audit facilities of vendors and outside contract organizations
-Play an active role in obtaining and maintaining any required pharmaceutical licences for marketing products in Europe
-Apply Risk Management where required.
-Assist in other quality assurance related activities as agreed with management.
-Assist in supporting Health Authority Inspections/Audits at Licensed Sites
-Electronic management of local QMS documents and records
-Assist in oversight of external QP/RPs to ensure compliant product release.

Requirements

Experience in launch processes of new products.
At least 8, but preferably 10 years of QA experience in regulated industry such as pharmaceutical or biologis, preferably in a position with similar responsibilities.
Experience with effectively managing regulatory agency inspections, working with regulators, and vendor/supplier audits.
Broad knowledge of risk-based quality systems approaches

• Master degree in Pharmacy, Chemistry, Life Science or related discipline.
• Full understanding of GDP and GMP.
• Understanding of medical device regulations.
• Understanding of EU inspection procedures.

• Must have excellent communication skills (verbal and written).
• Fluency in English
• Highly organized with a strong attention to detail, clarity, accuracy and conciseness.
• Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook).

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: 47805
Listed by: SIRE Life Sciences®
Listed on: 18-06-2019
Country: The Netherlands
Employment: Permanent
Expertise: 6 - 10 years
Location Type: Multiple locations
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

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