€ 35,000 - € 50,000
Quality & Safety, Engineering
Detachering via YER
Medical & Health, Food, Feed & Pharma
Over deze vacature
In this role, you are responsible for planning and execution of daily quality assurance activities while ensuring compliance with international quality requirements as defined by the applicable guidelines (e.g. FDA, EMA, ICH) and all existing GMP standards in the area of responsibility. This position involves judgement of batch related documents.
You are a proactive thinking team-player, accurate, precise and constructively critical.
Tasks and responsibilities:
- Plan and execute quality assurance activities (document management, batch records and label issuance, batch record review, equipment and supplier qualifications etc.) including documentation
- Monitor compliance with all applicable GMP and safety standards
- Support the Qualified Person in his role, including audits and quality training
- Write, review and approve documentation (SOP’s, manufacturing and quality instructions, validation of protocols and reports, non-conformities, change requests). Handle, distribute and archive controlled documents
- Prepare data for trending (QRB, Annual Product Review) and support internal and external audits
Pharmacell, located in Maastricht, is known as a contract manufacturing organisation in Europe for cell therapy and regenerative medicine.
You will be employed by YER and seconded to Pharmacell. Our benefits are very competitive and designed around your preferences:
- A competitive salary depending on experience
- Extensive set of tools to drive your career, such as a personal development budget, training and coaching
- Healthy work-life balance
Qualifications and skills:
- BSc in Chemistry/Biotechnology
- Knowledge of GMP is an advantage
- Good communication skills in English
- Accuracy, tidiness, self-organized, flexible, attention to detail, team player