QA Compliance Expert – cGxP & Audit Lead (Hybrid)

Novartis; Puurs-Sint-Amands; Híbrido; EUR 51.000 - 94.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Hybrid work

Parental leave

Insurance plans

Descripción de la vacante

Novartis in Puurs, Belgium, is seeking a QA compliance expert to ensure the Quality Management System stays compliant with cGxP requirements, including data integrity and regulatory alignment. You will act as a site SME for data integrity, audits, and CAPAs, collaborating with Manufacturing, QC labs, MS&T, Supply Chain, QA, and external partners to strengthen compliance.

Join a role focused on investigations, CAPAs, audits, continuous improvement, and readiness activities, contributing to

Formación

• Master’s degree in a scientific field such as Pharmacy, Industrial Pharmacy, Bio‑engineering, or related discipline.
• 3+ years of experience in a regulated environment, preferably within the pharmaceutical industry.
• Strong understanding of Good Manufacturing Practices and relevant pharmaceutical legislation.
• Proficiency in computer systems with the ability to work accurately with digital documentation.
• Excellent communication skills with the ability to collaborate effectively across teams and with external partners.
• Fluent Dutch and English, written and spoken.

Responsabilidades

• Ensure the site Quality Management System remains compliant with cGxP requirements, including data integrity.
• Implement, maintain, and continuously improve QMS processes and governance, aligned with Novartis standards and applicable regulations.
• Review, coordinate, and drive timely completion of deviations, investigations, CAPAs, and effectiveness checks, with strong focus on preventing recurrence.
• Plan, coordinate, and oversee APQR execution, ensuring timely completion, clear outcomes, and appropriate follow-up.
• Prepare for, support, and coordinate internal and external audits and regulatory inspections, including readiness activities and response follow-up.
• Provide clear explanations of QMS processes during internal and external audits.
• Maintain site licenses up to date and compliant with FAGG requirements
• Keep assigned procedures accurate, updated, and aligned with evolving operational requirements.

Conocimientos

Data integrity

Audits

CAPA

Documentation

Communication

Educación

Master’s degree in a scientific field (Pharmacy/Industrial Pharmacy/Bio-engineering)

Herramientas

Computer systems proficiency

Descripción del empleo

Novartis in Puurs, Belgium, is seeking a QA compliance expert to ensure the Quality Management System stays compliant with cGxP requirements, including data integrity and regulatory alignment. You will act as a site SME for data integrity, audits, and CAPAs, collaborating with Manufacturing, QC labs, MS&T, Supply Chain, QA, and external partners to strengthen compliance.

Join a role focused on investigations, CAPAs, audits, continuous improvement, and readiness activities, contributing to