Key Role in Pharmaceutical Logistics
As a Qualified Person, you will play a critical role in ensuring the quality and compliance of medicinal products for both human and veterinary use. You will act as a liaison with public health authorities and contribute to the development of production files, SOPs, work instructions, and associated documentation.
Responsibilities:
* Act as the primary point of contact for public health authorities, including the Federal Agency for Medicines and Health Products.
* Develop and maintain production files, SOPs, and work instructions to ensure compliance with GMP/GDP regulations.
* Manage compliance regarding narcotics, psychotropic substances, and precursor distribution.
* Oversee the handling of non-conforming products, including returns, recalls, and destruction.
* Participate in client audits and internal/external inspections.
* Lead deviation management, complaint handling, and root cause analysis of non-conformities.
* Approve suppliers, service providers, and clients within the QA framework.
* Monitor site metrology and ensure appropriate storage conditions for all medicinal products (cold chain, ambient, frozen).
Requirements:
* Masters degree in Industrial Pharmacy, entitling you to act as a Qualified Person.
* Demonstrated QA experience in a GxP-compliant environment (GMP/GDP).
* Strong sense of responsibility and commitment to high-quality standards.
* Self-motivated, proactive, and capable of working autonomously with ownership of your domain.
* Fluent in English and Dutch.
Benefits:
* Comprehensive hospitalization insurance.
* Generous monthly net allowance.
* Flexible working hours.
* Hybrid work model.
* Suitable onboarding, training, and development pathways.
About the Position
This is a key position that plays a vital role in driving our operations forward. As a Qualified Person, you will be responsible for ensuring the quality and compliance of medicinal products, and contributing to the development of production files and other documentation. If you are self-motivated, proactive, and have a strong sense of responsibility, this could be the ideal opportunity for you.