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Sterility Assurance Specialist
2 maanden geleden
About the Role
We are seeking a highly skilled Sterility Assurance Specialist to join our team at Prothya Biosolutions. As a key member of our quality team, you will be responsible for ensuring the sterility of our products by designing, implementing, and monitoring processes and control systems that prevent and control microbial contamination.
Key Responsibilities
- Design and implement processes and control systems to prevent and control microbial contamination.
- Work closely with production and quality departments to ensure compliance with regulations and industry standards.
- Evaluate processes, systems, and equipment within the field of contamination control.
- Provide advice on product sterility and contamination control, and assess the impact of deviations that pose a potential hazard to product sterility.
- Contribute to investigation and root cause analysis of microbiological issues.
- Set up and lead the Contamination Control Board.
- Support the microbial assurance aspects of the Quality System.
- Coordinate the use of all microbial services.
- Support the review and development of procedures for all microbial assurance activities.
- Implement the GMP training program for clean room and other appropriate staff.
- Support the Quality team in the preparation for and performance of all audits and inspections as Subject Matter Expert for Contamination Control.
- Lead multidisciplinary projects in this specialist area.
Requirements
- 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.
- Experience in 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.
What We 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.
