QA Project Specialist

As a
QA Project Specialist
, you will play an important role in the quality assurance of our change control projects. You will be responsible for ensuring compliance with cGMP guidelines and will act as the connecting link between various departments within Prothya. This role requires a proactive attitude and in-depth knowledge of quality processes within a pharmaceutical environment. With your expertise, you will help our organization to continuously improve and efficiently organize our processes, so that we meet the highest quality and safety standards.

Main Responsibilities

• Project management within Change Control: Guiding and contributing to change control projects within the production environment. You represent the QA department in project teams and ensure that validation requirements and quality guidelines are adhered to.
• Compliance and Advice: Act as Subject Matter Expert (SME) in the field of compliance and quality assurance. You assess and monitor the quality impact of changes and advise internal teams during audits and inspections.
• Data Integrity and Master Data Management: Ensuring compliance with change control processes, including control of documentation, reporting and systems. You manage Master Data and ensure complete, correct reporting in line with internal and external requirements.
• Policy Development and Implementation: Develop and roll out change control policies within the organization. Translate strategies into practical guidelines and provide training and guidance to colleagues to promote quality standards.
• Stakeholder Management: Coordinating and aligning with internal and external stakeholders. You know how to create support for quality initiatives and promote cooperation by acting tactfully and convincingly.

Your profile

• We are looking for a QA Project Specialist with excellent analytical and organizational skills, who is a strong communicator and feels at home in a dynamic environment. In addition, you recognize yourself in the following profile:
• Bachelor or Master education in a technical, chemical or biotechnological direction.
• Minimum 3 years of work experience in quality management or QA in a cGMP environment, in the pharmaceutical or biotechnology sector.
• In-depth knowledge of cGMP guidelines and experience with change control and validation processes.
• Proactive attitude and a structured approach, with the ability to make decisions within complex project environments.
• Excellent oral and written communication skills in English and preferably in Dutch as well.
• Experience in leading projects and coordinating multidisciplinary teams.
• Ability to work on-site in Amsterdam for at least 3-4 days per week.

What do we offer?

• Full-time employment (40h) with flexible working hours in consultation. Working part-time can be discussed.
• 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.
• Excellent accessibility by public transport and private parking available.
• A pension plan with Zorg & Welzijn, providing security for your future.
• 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

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.