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, preferably in the pharmaceutical or life sciences 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 Dutch and English.
• Experience in leading projects and coordinating multidisciplinary teams.

What do we offer?

• At Prothya Biosolutions you will have the opportunity to be part of a passionate team that makes a difference in healthcare. We offer:
• A challenging and responsible position in which your expertise and ideas are welcome.
• Opportunities for professional development and training, both short and long term.
• A competitive salary, supplemented with excellent secondary employment conditions.