Description
Quality Assurance Manager - GDP , PermanentWe are seeking an experienced individual to join a start up team as Manager of QA/Deputy QP. This opportunity presents a unique challenge to leverage the well-established medicine while simultaneously building a new, unique culture focused on growth, profitability, and long-term vision.
The Manager of QA/Deputy QP support the Qualified Person on the assessment of cGMP compliance of medicinal products' production; cGDP compliance of medicinal products' distribution; and the maintenance of a functional and inspection ready internal Quality System.
In this role, he/she supports the QP for the final decision on batch release or rejection.
Main Responsibilities:
- Release medicinal products to the EU markets.
- Work across all functions (Supply Chain, Regulatory Affairs, Development, etc.) to support and ensure that all applicable internal Quality Standards/Policies and legislative requirements are maintained.
- Supports identification of gaps/risks and opportunities for continuous improvement in the Quality System and their remediation and implementation respectively.
- continuously follows new regulatory regulations and guidelines and discusses/proposes their implementation, when deemed necessary.
- Support GMP/GDP vendor auditing program
- Ensure that GxP related internal documents (policies, SOPs, etc.) are up to date, timely reviewed and made effective and support the global training coordinator for local training in the Netherlands.
Required Background and Skills:
Education to a pharmacy degree (study of at least four years)
A minimum of 5 years' experience in pharma/biotech industry (manufacturing, QC, QA)
Previous experience with batch release to market is a strong plus.
Hands on experience of Good Manufacturing Practices and Good Distribution Practices in the pharmaceutical environment
Experience with management of Quality Systems in manufacturing, warehousing and distribution
Team player and excellent communication skills.
Excellent organizational skills and great attention to details.
English is the company language. Knowledge of Dutch is a plus.
This opportunity offers a variety of tasks across quality assurance area in GMP and GDP and also to become a part of a project, which aims to build the operation and processes to become and bigger and more successful company.
Michael Bailey International is acting as an Employment Agency in relation to this vacancy.