QA Specialist

Bedrijfsnaam: -
Plaatsingsdatum: 04/04/2019
Standplaats: -


SIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!Our client is a professional Pharmaceutical organisation, based in Noord-Holland Netherlands.The Company.

Role DescriptionYou 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

ResponsibilitiesReceipt 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.

RequirementsMinimum 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.

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.




Plaatsingsdatum :
Referentienummer :
Standplaats :
Adres :
Postcode :
9723 HK
Opleidingsniveau :
Uren :
Nader te bepalen
Dienstverband :
Werkervaring :
3 - 5 jaar
Contactgegevens :