Senior Sterility Assurance Specialist Amsterdam • Prothya Biosolutions

Your responsibilities:

• Ensure the sterility of Prothya's products by designing, implementing, and monitoring processes and control systems to prevent and control microbial contamination.
• Collaborate closely with both the production and quality departments to ensure compliance with regulations and industry standards, such as those described in Annex 1.
• Evaluate processes, systems, and equipment, including setting up Environmental and Utility Monitoring programs and establishing the Contamination Control Strategy (CCS).
• Provide advice on product sterility and contamination control, assess deviations posing potential hazards to sterility, and contribute to investigations and root cause analyses of microbiological issues.
• Lead the Contamination Control Board and co-ordinate microbial services.
• Support microbial assurance aspects of the Quality System and review/develop procedures for microbial assurance activities.
• Implement GMP training programs for cleanroom and other relevant staff.
• Act as the Subject Matter Expert for Contamination Control during audits and inspections.
• Lead multidisciplinary projects in the area of microbial assurance.

Your profile:

• BSc degree or higher in a relevant field (pharmaceuticals, microbiology, biology, etc.).
• At least 10 years of experience within a pharmaceutical production environment.
• Strong microbiological knowledge and experience implementing EU requirements, including Annex 1, and setting up a Contamination Control Strategy.
• Proven experience with contamination control processes.
• Proactive team player with excellent communication and influencing skills.
• Experience conducting GMP audits, both internal and external.
• Fluent in English; proficiency in Dutch is a plus.

What we offer:

• A competitive salary between €75,000 and €90,000 per year, depending on experience.
• 8.33% end-of-year bonus and 8.33% holiday allowance.
• Flexible working hours in consultation.
• Personal training budget of €2,000 every 3 years.
• Contribution to travel expenses from the first kilometre.
• Good accessibility by public transport and private parking.
• Pension plan with Zorg & Welzijn.

More info:

If you would like to know more about this vacancy, please contact our recruitment department via de button "Solliciteer nu" op deze pagina.. Do you recognise yourself in this profile and want to take on this challenge at Prothya Biosolutions? Then we’d love to receive your resume and motivation letter via the apply button on this page. We aim to respond within a week.

Acquisitie wordt niet op prijs gesteld. Prothya aanvaardt geen ongevraagde hulp van bureaus voor deze vacature. Toegestuurde cv's (in welke vorm dan ook) door bemiddelingsbureaus aan enige medewerker van Prothya zonder geldige schriftelijke zoekopdracht, worden gezien als eigendom van Prothya waarvoor op geen enkele wijze een vergoeding verschuldigd is.