Benelux CQA Specialist — Quality & Regulatory Lead

Vantive; Eigenbrakel; Vor Ort; EUR 62.000 - 90.000; Vollzeit

Zusammenfassung

Vantive seeks a CQA Specialist to ensure compliance across regulatory licenses (WDA & MIA) and quality systems within the Benelux. You will coordinate with Regulatory Affairs, Pharmacovigilance and logistics to maintain certifications such as ISO 9001 and ISO 13485.

You will lead post-market surveillance, support quality initiatives, and act as a back-up Responsible Person. Fluency in Dutch or French and English, along with GMP/GDP knowledge, are essential.

Qualifikationen

• Master degree in pharmaceutical sciences, medicine, chemistry, biology, biomedical sciences or bio engineering.
• Eligible as Responsible Person.
• Experience in quality in pharma/medical devices preferred.
• Fluency in Dutch or French, and working proficiency in the other language and English.
• Office basic knowledge.
• Knowledge of GDP and GMP standards and quality systems.
• Product and process validation methodology.
• Knowledge of Medical Industry Processes.
• IT functional knowledge (ERP, data management).
• Strong interpersonal and communication skills.
• Organizational and project management skills.
• Self-motivation and commitments.
• Trackwise, JDE, ERP systems knowledge is a plus.
• ISO Certification knowledge is appreciated.

Aufgaben

• Maintain related regulatory licenses (WDA & MIA).
• Ensure outsourced storage and distribution comply with European and local requirements and implement quality systems.
• Act as the Post Market Surveillance and local contact for medical devices.
• Provide Quality Support to local business initiatives with Quality Operations.
• Maintain contacts with Regulatory Affairs, Pharmacovigilance, 3PL, transporters and businesses.
• Responsible Person Back-up.

Kenntnisse

Fluency in Dutch or French

English proficiency

Office basic

GDP/GMP knowledge

Product/Process validation

Medical industry knowledge

IT functional knowledge

Interpersonal skills

Organizational/Project mgmt

Self-motivation

Trackwise/JDE/ERP familiarity

ISO Certification knowledge

Ausbildung

Master Degree in Pharmaceutical Sciences or related

Tools

ERP systems

JDE

Trackwise

Jobbeschreibung

Vantive seeks a CQA Specialist to ensure compliance across regulatory licenses (WDA & MIA) and quality systems within the Benelux. You will coordinate with Regulatory Affairs, Pharmacovigilance and logistics to maintain certifications such as ISO 9001 and ISO 13485.

You will lead post-market surveillance, support quality initiatives, and act as a back-up Responsible Person. Fluency in Dutch or French and English, along with GMP/GDP knowledge, are essential.