Daily new jobs

 

QA Specialist

Share on social media:

Apply Save this job

8 people also applied on this job


The company

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

Role description

You are able to think out of the box for this role. You also have good interpersonal, verbal and written communication skills in English
A team player with a can-do attitude.
Comfortable in a fast-paced Multinational environment with minimal direction and able to adjust workload based upon changing priorities

Responsibilities

Receipt and disposition of incoming materials (if applicable).
Ensures that associated CAPAs are initiated and resolved, as needed.
Ensure Change Controls are initiated, evaluated and implemented appropriately for all regulated changes.
Contribute to the maintenance and reporting of metrics related to batch record review and product disposition in support of the Management Review.
Contribute to the development and implementation of Quality on the floor processes, including batch record review, and deviation handling.
Review batch-related documentation, and ensures resolution of issues to release product.
Perform preparations for product disposition/lot closure by the QP.
Ensure all product-related Deviations are initiated, investigated and resolved.
Apply lean thinking to ensure continuous improvement project.
Intake and handling of product complaints for EU and/or related investigations.
Assist with implementation and maintenance GMP training system in EU.
Support inspection readiness plans and interact with regulatory agencies during inspections as needed.
Oversee the packaging and shipping process for EU.
Oversee the product disposition process for EU.

Requirements

Minimum of 2 years’ progressive quality or manufacturing experience in a pharmaceutical, biotech, or biologics operation
Working knowledge and ability to apply GMPs in conformance to U.S. and EU standards
Strong knowledge of GMP, including GDP and preferably Lean principles.

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.

Job alert

  • No registration required
  • Stay up-to-date on the latest jobs

SIRE Life Sciences®

Ref. number: 47286
Listed by: SIRE Life Sciences®
Listed on: 03-04-2019
Country: The Netherlands
Region: Noord-Holland
Employment: Permanent
Expertise: 3 - 5 years
Location Type: On location
Education: Bachelor
Language: English
Sector: Pharmaceutical
Specialisation: Quality

Search again

Related jobs

SIRE Life Sciences®
Regulatory Affairs Officer

The Netherlands
Permanent
Quality

SIRE Life Sciences®
Team Leader Quality Assurance

The Netherlands
Permanent
Quality

SIRE Life Sciences®
Senior QA & Compliance Officer

The Netherlands
Permanent
Quality

SIRE Life Sciences®
Qualified Person

The Netherlands
Permanent
Quality

SIRE Life Sciences®
Quality Assurance Specialist

The Netherlands
Permanent
Quality

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

Product Price