Senior QA Lead, QP/RP - Global Compliance & Launch

Derks & Derks

Ankeveen

Sur place

EUR 90 000 - 130 000

Plein temps

Il y a 2 jours

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Résumé du poste

Eurocept Pharmaceuticals in the Netherlands seeks a Senior Quality Assurance Lead / QP & RP to maintain and drive pharmaceutical quality and regulatory compliance. You lead the Quality team, coordinate audits, and ensure market release of products in line with GxP standards.

In this senior role you will develop the QMS, oversee CAPAs, change controls, batch certification, PQRs and stability studies, and support international collaborations and product launches while fostering a strong quality

Qualifications

Master’s degree in a scientific discipline relevant to pharma.
Extensive GMP/GxP knowledge and regulatory compliance.
Experience leading quality initiatives and teams.
Strong analytical and decision-making skills in QMS.
Excellent communication and project management abilities.

Responsabilités

Lead QA activities and ensure QP & RP responsibilities meet regulatory standards.
Develop, implement and improve the QMS, SOPs, CAPAs and change controls.
Coordinate internal/external audits and support regulatory inspections.
Oversee batch certification, PQRs, stability studies and narcotics management.
Drive quality improvements, investigations and supplier/customer qualifications.