Your new company
Our client is an organisation committed to providing high quality plasma-derived products. This is done through complex methods used to isolate proteins from blood plasma to transform them into life-saving medicines. Not only are they committed to patient care, they also develop advanced solutions for client partners. Prothya's colleagues go the extra mile to deliver top quality patient care worldwide!
Your new role
The Sterility Assurance Specialist (SAS) is tasked with ensuring the sterility of our products by designing, implementing and monitoring processes and control systems that prevent and control microbial contamination. This specialist works closely with both the production and quality departments to ensure compliance with regulations and industry standards, as described in Annex 1, for example.
Responsibilities include evaluating processes, systems and equipment within this field, establishing the contamination control strategy (CCS), providing advice to the organisation regarding product sterility and contamination control, and assessing the impact of deviations that pose a potential hazard to product sterility. Leading multidisciplinary projects in this specialist area is also part of the tasks of this role.
What you'll need to succeed
HBO+ in Life Sciences with 5+ years’ experience in a pharmaceutical/ biotechnology environment. Have a detailed knowledge of the legal and regulatory framework regarding Sterilization and Environmental monitoring. Have strong microbiological knowledge is essential for this role, as well as experience with implementation of EU requirements as laid down in annex I. The ideal candidate will have experience conducting GMP audits, internal and relevant external audits. They should have excellent communication, preferably both Dutch and English.
What you'll get in return
Hays Detachering | This is a project that will start with a contract for 4 months through Hays. At this position, you will get a competitive salary and your travel expenses are covered
What you need to do now
If you are interested in this role as ”Sterility Assurance Specialist”, click ‘Apply now’ to send an up-to-date CV, or give us a call! Is this job isn’t quite right for you, but are you still looking for a new position? Please contact us for a confidential discussion on your career.