Über die Tätigkeit
Fagron is looking for a Quality Assurance Project Manager to manage different projects in order to optimize our quality processes in line with the business needs. You will be focusing on the quality within the complete flow from raw material to product for our different production sites. Your aim is to strive, to achieve optimum quality and to make the processes more efficient. As Qualified Person you will also responsible for the final release of the batch of our pharmaceutical product. In this role you review all the batch files, which encompass information from every involved department.
In first instance you will focus on our production site in Uitgeest, The Netherlands. On the mid-term, you may also become responsible for quality projects at other European production sites, inside and outside The Netherlands. In your role you will report to the European Quality Manager.
Your responsibilities include but are not limited to:
- Determine the policy lines in the framework of the entire quality process
- Translating the Global and European quality strategy into quality in actual projects for our production sites
- Act as Qualified Person and ensure certification of each batch of the finished products
- Developing and rolling out training material in the field of GMP for employees within the various locations
- Following the principles and guidelines of GMP according to ICH, EU Annexes, and industry best practices. Ensure all requirements under references have been met prior to release of a batch
- Validation of the principal manufacturing and testing processes
- Checking all necessary tests have been performed
- Ensuring that the legal requirements regarding imported products have been fully met
- Providing QP GMP declarations in support of importation activities and maintaining an up-to-date awareness of regulatory issues
- Carry out auditing of third party GMP facilities involved in the manufacturing of medicinal products, active pharmaceutical ingredients, excipients, and other necessary materials used in production or ancillary activities.
- Drawing up action plans for inspections / audits and monitoring their follow-up
- Identifying and eliminating GMP risks within the various locations
- Has a M.Sc. degree in Pharmacy, Biotechnology, Biology or equivalent?
- Is licensed as QP as defined in the DIRECTIVE 2001/83/EC
- Has at least five years of experience working in a GMP regulated environment
- Has experience in performing audits of third-party providers and support of the internal audit program to enable permanent inspection readiness
- Has an excellent proficiency in English and in Dutch.
We offer a unique working environment where talent and ambition can develop to its fullest. We have an open and informal organization culture, where you need to be able to work independently. Fagron is a young, professional and ambitious company with plenty of growth opportunities and we will offer you a competitive compensation