QA Compliance Specialist: Data Integrity & Audits

BE13 (FCRS = BE013) Novartis Manufacturing NV; Puurs; Hybrid; EUR 51,000 - 94,000; Full time

Job summary

Novartis Puurs site seeks a QA compliance specialist to safeguard cGxP compliance and ensure the Quality Management System meets international and local regulations.

You will act as a site SME for data integrity, audits, deviations, CAPAs and inspections, collaborating with Manufacturing, QC, MS&T, Supply Chain and external partners. This role supports continuous improvement and regulatory readiness with FAGG-licensed processes, in a hybrid work setup.

Qualifications

• Master’s degree in a scientific field is required.
• 3+ years of experience in a regulated environment, preferably in pharma.
• Strong understanding of Good Manufacturing Practices and pharmaceutical legislation.
• Proficiency with computer systems and digital documentation.

Responsibilities

• Ensure the site Quality Management System remains compliant with cGxP requirements including data integrity.
• Implement, maintain, and improve QMS processes and governance per Novartis standards and regulations.

Skills

Audits

Compliance

Collaboration

Communication

Data Integrity

Decision Making

Internal Auditing

Managing Ambiguity

Problem Solving

Process Quality Assurance

Quality Assurance (QA)

Quality Auditing

Quality Compliance

Quality Management

Quality Management System

Regulatory Compliance

Validation Activities

Validation Management

Education

Master's degree in science

Job description

Novartis Puurs site seeks a QA compliance specialist to safeguard cGxP compliance and ensure the Quality Management System meets international and local regulations.

You will act as a site SME for data integrity, audits, deviations, CAPAs and inspections, collaborating with Manufacturing, QC, MS&T, Supply Chain and external partners. This role supports continuous improvement and regulatory readiness with FAGG-licensed processes, in a hybrid work setup.