QA Compliance Expert — Hybrid Work in Pharma Quality

Novartis Belux; Puurs; On-site; EUR 51,000 - 94,000; Full time

Benefits offered by this job

Flexible and hybrid working options

14 weeks paid parental leave

Insurance plans

Retirement plans

Wellbeing resources

Global recognition programs

Job summary

Novartis Belux in Puurs, Belgium, is seeking a QA compliance specialist to safeguard cGxP adherence across site activities and data integrity. You will coordinate deviations, investigations and CAPAs while supporting audits and regulatory inspections.

The role requires a Master’s in a scientific field and 3+ years in a regulated pharma environment, with strong Dutch and English skills and proficiency with digital documentation.

Qualifications

• Master's degree in a scientific field such as Pharmacy, Industrial Pharmacy, Bio‑engineering, or related discipline.

Responsibilities

• 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.

Skills

Data integrity

Audit & inspection management

Deviation investigations

CAPA execution

Cross-team collaboration

Communication skills

Dutch language

English language

Computer systems proficiency

Education

Master's degree in Pharmacy / related field

Job description

Novartis Belux in Puurs, Belgium, is seeking a QA compliance specialist to safeguard cGxP adherence across site activities and data integrity. You will coordinate deviations, investigations and CAPAs while supporting audits and regulatory inspections.

The role requires a Master’s in a scientific field and 3+ years in a regulated pharma environment, with strong Dutch and English skills and proficiency with digital documentation.