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Join Prothya Biosolutions and be a pivotal part of a team that champions quality and innovation in the life sciences. We are currently looking for a skilled Senior Quality Systems Officer to reinforce our global quality assurance framework and drive continuous improvements.
Full-time | Amsterdam, Netherlands or Brussels, Belgium
About the Role:
As a Senior Quality Systems Officer, you will be responsible for overseeing the Quality Management System (QMS), ensuring its compliance with GMP standards and facilitating process optimisation. Your role will involve managing document control through our system (MasterControl), liaising with stakeholders, and fostering improvements to meet evolving industry standards.
Key Responsibilities:
- DMS Management: Oversee the maintenance and continuous improvement of the DMS, ensuring alignment with industry regulations.
- System Oversight: Act as the primary point of contact for the DMS (MasterControl), coordinating with IT for system enhancements and addressing issues.
- Process Improvements: Lead initiatives to optimise document and quality processes, ensuring that they contribute to operational excellence.
- Training & Support: Provide comprehensive training and support for staff on DMS procedures and system utilisation.
- Workflow Efficiency: Ensure effective distribution of tasks within the DMS and resolve any issues related to task assignment.
- Stakeholder Engagement: Collaborate across departments to ensure compliance, gather feedback, and implement solutions that improve system functionality.
- Be a back-up for the Docusign key-user
Your Profile:
- Experience: A minimum of 5 years in quality assurance within the pharmaceutical sector, ideally with experience in quality systems or document control.
- Skills: Excellent communication, stakeholder management, and problem-solving abilities, with the drive to implement and manage system improvements.
- Education: Bachelor’s degree in life sciences, quality management, or a related field.
- Languages: Fluent in English. Dutch or French proficiency is beneficial.
- Technical Knowledge: Familiarity with MasterControl or equivalent quality systems software is highly advantageous.
- Experience in GMP
What We Offer:
- Full-time employment with flexible working hours in consultation.
- Salary between € 4.379,34 to € 6.295,23
- 8.33% end-of-year bonus and 8.33% holiday allowance.
- A personal training budget of €2,100 every three years to foster professional growth and development.
- Contribution to travel expenses from the first kilometer.
- A pension plan with Zorg & Welzijn, providing security for your future.
- A challenging position with significant impact on quality systems and practices.
- Opportunities for career development and contribution to critical quality initiatives.
- A collaborative and diverse work environment with international colleagues.
- Excellent accessibility by public transport and private parking available.
- A dynamic, safe, and challenging working environment with ample opportunities to grow, innovate, and learn, all while making a meaningful impact on the health of millions
Why Choose Prothya Biosolutions?
At Prothya Biosolutions, we are dedicated to delivering high-quality plasma-derived products that make a difference in patients' lives. By joining our team, you will help shape essential quality processes and play a crucial role in our mission to enhance patient care.
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.