Senior Quality Assurance Manager GDP/GMP
Posted on Feb 7, 2020 by Michael Bailey Associates - Zurich
Global pharmaceutical company, with an affiliate office in Netherlands - Amsterdam is looking for a Quality Assurance Manager to support the current quality assurance activities related to GMP and GDP.
* 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 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:
* Diploma in pharmacy (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.
Michael Bailey International is acting as an Employment Agency in relation to this vacancy.