Periode: Project with possible permanent extension
Our client is a leading Project Management and Engineering Company serving industry around the world. Their reputation is based on forming successful partnerships with their clients, providing them with innovative designs and cost effective solutions in the context of sound judgment, strong management and technical excellence.
They provide Full Service Engineering for their clients including Project and Programme Management, Procurement, Design, Construction Management, Health & Safety Management, Commissioning, Qualification and Start-up on numerous projects across a range of market sectors.
Responsible for the Commercial Quality Release activities in Quality Center NL in alignment with business unit, in order to ensure products are efficiently distributed into The Netherlands and other European countries. Including the release of clinical supplies by meeting client, regional and local standards and customer needs. As well manage the Commercial Quality Release team.
- Ensure GMP &GDP compliance at the commercial unit and promote quality culture.
- Create, maintain up-to-date and distribute SOP and Working Instructions in compliance with national regulations.
- Ensure GMP and GDP training at a local level.
- Initiate continuous improvement of processes.
- Lead Local Cross functional Quality Council.
- If applicable, ensure a system is in place to manage and review Product Quality Reviews for local products.
- Attend to European monthly quality councils.
- Provide the relevant data to the European Commercial Quality local monthly quality metrics.
- Ensure QP batch certification according to GMP Annex 16 for products including clinical supplies as service for R&D, for NL market as well as European countries.
- Ensure quality complaints are registered and liaise with manufacturing site to trigger corresponding investigation and adequate corrective actions.
- Administer, maintain and develop systems for change control, deviation and CAPA handling
- Master´s Degree in Pharmacy, Medicines, Biology or an equivalent combination of education and experience to the functional role.
- Demonstrated knowledge and working experience with government regulations for the country.
- In-depth knowledge of pharmaceutical industry as it relates to Quality Compliance.
- Working knowledge of pharmaceutical operations.
- In-depth understanding of cGMP & GxP's regulations.
- Experience with development and implementation of Quality Systems and application of risk assessment tools.
- Proficient computer skills in current software including MS Office.
- Excellent English.