Quality Systems Specialist at Pharming Group NV
Pharming Group N.V. is committed to the development of innovative products for the treatment of unmet medical needs. We focus on the development and production of human therapeutic proteins to provide life-changing solutions to patients.
Quality Systems Specialist
Based in: Leiden - Fulltime position
Pharming Group N.V. develops innovative protein therapeutics for the treatment of genetic disorders.
At this moment, the company is composed for further science, technology and new product develop-ment and commercial roll-out. The company is small (approx. 150 employees, based international) and entrepreneurial. The Quality Systems Specialist must fit in this organizational culture where integrity, entrepreneurship and flexibility are core competencies.
As part of the Quality Assurance (QA) team, you provide support on the efficient (c)GMP quality systems for Pharming's products. The quality systems apply to both internal procedures as well as systems at our contract-partners and suppliers. The necessary control functions are executed by review of documentation and by performing audits on (provider's) sites.
In addition, as the specialist on system automation and validation (acc. GAMP5) , you have a leading role in the configuration, validation, implementation and maintenance of efficient (c)GMP quality systems. The automated quality system will be composed of a Documentation Management System, a Quality Management System and a Learning Management System. Setting up and maintaining an integrated data interaction between the (c)GMP quality systems and other internal and external management systems (Regulatory Information, Clinical Data, Laboratory Information, Enterprise Resource Planning, etc..) will be part of the job.
After implementation, you remain responsible for the yearly updates and revalidation, including addition of new applications to the (c)GMP quality systems. You will provide service to all users of the (c)GMP quality systems, investigate and solve issues when required, in a quality manner. This includes the technical support and interaction with the vendors of our (c)GMP quality systems.
Note: although mainly based in Leiden, it may incidentally be necessary to perform tasks on either of the other locations in the east of the Netherlands or in France.
- Bachelor's degree in biotechnology, biopharmaceutical sciences, (bio)chemistry, ICT or alike.
- Knowledge of quality systems (such as ISO 9001:2008), pharmaceutical Quality systems ((c)GxP) and in particular EU-GMP Annex 11, US-CFR21 part 11 and GAMP-5.
- Two to three years of experience in (bio)pharmaceutical production, quality control or quality assurance and at least three years of experience with automated Documentation and Quality Management system(s). Affinity and preferably also experience with ERP or SAS systems.
- Analytical, accurate, pro-active, independent.
- Effective communicator in conversation and writing, in Dutch and English.
- Experienced with the use of MS-Office programs.
For more information please contact Nienke van der Veer; firstname.lastname@example.org or call 071 524 74 68.
For all recruitment agencies: don't call us, we call you!