Pharmaceutical Quality Assurance Specialist
About the Role:
We are seeking a highly skilled and experienced Pharmaceutical Quality Assurance Specialist to join our team. As a key member of our quality assurance department, you will play a critical role in ensuring the highest standards of quality and compliance within our organization.
Your Responsibilities:
* Liaise with Regulatory Authorities: Act as the primary point of contact with public health authorities, including the Federal Agency for Medicines and Health Products (FAMHP), to ensure seamless communication and compliance.
* Development of Quality Documentation: Contribute to the creation of production files, SOPs, work instructions, and associated documentation to maintain the highest level of quality assurance.
* Compliance Management: Oversee compliance regarding narcotics, psychotropic substances, and precursor distribution to ensure adherence to regulatory requirements.
* Non-Conforming Product Management: Handle non-conforming products, including returns, recalls, and destruction, to minimize any potential impact on our operations.
* Client and Internal Audits: Participate in client audits and internal/external inspections to ensure compliance and identify areas for improvement.
* Deviation Management: Lead deviation management, complaint handling, and root cause analysis of non-conformities to maintain the highest level of quality assurance.
* Supplier and Service Provider Approval: Approve suppliers, service providers, and clients within the QA framework to ensure compliance and reliability.
* Site Metrology and Storage Conditions: Monitor site metrology and ensure appropriate storage conditions for all medicinal products (cold chain, ambient, frozen) to maintain their potency and integrity.
Your Profile:
* Education: Master's degree in Industrial Pharmacy, entitling you to act as a Qualified Person.
* Experience: Demonstrated QA experience in a GxP-compliant environment (GMP/GDP).
* Skills and Qualifications: Strong sense of responsibility and commitment to high-quality standards; self-motivated, proactive, and capable of working autonomously with ownership of your domain.
* Language Requirements: Fluency in Dutch and English.
Benefits:
* Meal Vouchers: Enjoy meal vouchers worth €8 per working day.
* Comprehensive Insurance: Receive comprehensive hospitalization insurance.
* Generous Allowance: Receive a generous monthly net allowance.
* Flexible Working Hours: Enjoy flexible working hours (start between 7:30 and 10:00).
* Hybrid Work Model: Benefit from up to 2 remote days per week.
* Onboarding and Development: Supportive onboarding, training, and development pathways—because your growth matters.