QA Compliance Specialist — Data Integrity & Audits (Pharma)

Novartis; Puurs; Hybrid; EUR 51,000 - 94,000; Full time

Benefits offered by this job

Insurance plans

Retirement plans

Wellbeing resources

Global recognition programs

Flexible and hybrid working options

14 weeks paid parental leave

Job summary

Novartis in Puurs, Belgium, is seeking a QA Compliance Specialist to safeguard cGxP compliance across site and product activities, ensuring data integrity and adherence to Novartis quality standards. You will partner with Manufacturing, QC, MS&T, Supply Chain and external partners to drive investigations, CAPAs, audits and continuous improvement.

The role requires a Master’s degree in a scientific field and 3+ years in a regulated environment, with fluent Dutch and English.

Qualifications

• 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.

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

Communication skills

Fluent Dutch

Fluent English

Education

Master's degree in a scientific field

Job description

Novartis in Puurs, Belgium, is seeking a QA Compliance Specialist to safeguard cGxP compliance across site and product activities, ensuring data integrity and adherence to Novartis quality standards. You will partner with Manufacturing, QC, MS&T, Supply Chain and external partners to drive investigations, CAPAs, audits and continuous improvement.

The role requires a Master’s degree in a scientific field and 3+ years in a regulated environment, with fluent Dutch and English.