Contamination Control Expert
6 dagen geleden
Job Description
This is a challenging role for an experienced Contamination Control Expert to join Prothya Biosolutions, a leading company in the field of biotechnology.
The salary for this position is around €80,000 per year, taking into account the location and industry standards.
About the Role
- We are seeking a highly skilled professional with a strong background in microbiology and contamination control to lead our efforts in ensuring the sterility of our products.
- You will be responsible for designing, implementing, and monitoring processes and control systems that prevent and control microbial contamination.
- You will work closely with the production and quality departments to ensure compliance with regulations and industry standards.
- You will evaluate processes, systems, and equipment within the field of contamination control, including assessing and setting up Environmental and Utility Monitoring programs.
- You will provide advice on product sterility and contamination control, as well as assess the impact of deviations that pose a potential hazard to product sterility.
- You will contribute to investigation and root cause analysis of microbiological issues, and 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, and support the Quality team in the preparation for and performance of audits and inspections.
- You will lead multidisciplinary projects in the specialist area of contamination control.
About You
- 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 related to contamination control.
- Proactive attitude and good team player skills.
- Good influencing skills with the ability to coach and guide teams across different business units.
- Experience of conducting GMP audits, internal and external audits.
- Excellent communication skills, with fluency in English and preferably Dutch.
About the Company
Prothya Biosolutions offers a dynamic and challenging work environment with opportunities for career growth and professional development.
We offer flexible working hours, a personal training budget, contribution to travel expenses, good accessibility by public transport and private parking, and a pension plan at Zorg & Welzijn.
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