Sterility Assurance Specialist

1 week geleden

Amsterdam, Nederland Prothya Biosolutions Voltijd

Your responsibilities

The Sterility Assurance Specialist is tasked with ensuring the sterility of Prothya´s products by designing, implementing and monitoring processes and control systems that prevent and control microbial contamination. You will work closely with both the production and quality departments to ensure compliance with regulations and industry standards, as described in Annex 1, for example. You will be evaluating processes, systems and equipment within this field, including the assessment and set up of the Environmental and Utility Monitoring programs, as well establishing the contamination control strategy (CCS). You will provide advice to the organization regarding product sterility and contamination control, and assessing the impact of deviations that pose a potential hazard to product sterility, as well as contribution to investigation and root cause analysis of microbiological issues. You will set up and lead the Contamination Control Board. You will support the microbial assurance aspects of the Quality System. You will co-ordinate use of all microbial services. You will support the review and development of procedures for all microbial assurance activities. You will implement the GMP training program for clean room and other appropriate staff. You will support the Quality team in the preparation for and performance of all audits and inspections as Subject Matter Expert for Contamination Control. You will lead multidisciplinary projects in this specialist area.

Your profile

BSc degree or above in a relevant field (pharmaceutical, microbiology, biology…) Strong microbiological knowledge and experience with implementation of EU requirements as laid down in annex I, including the set up of a contamination control strategy. Experience on processes in the field of contamination control- Proactive attitude and good team player. Good influencing skills with the ability to coach and guide teams across different business units. Experience of conducting GMP audits, internal and relevant external audits. Excellent communication skills. Ability to communicate fluently in English and preferably in Dutch.

Our offer

Full-time employment 8.33% end of year bonus and 8.33% holiday allowance Flexible working hours in consultation Personal training budget of €2,000 per 3 years Contribution to travel expenses from the first kilometer Good accessibility by public transport and private parking Pension plan at Zorg & Welzijn

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