Radiopharma Batch Release QA Specialist

NL42 (FCRS = NL042) IDB Holland BV; Baarle-Nassau; On-site; EUR 56,000 - 104,000; 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 the Netherlands seeks a Qualified Person responsible for batch release, ensuring product quality and compliance with applicable regulatory requirements, including cGMP, Dutch legislation, and European regulations.

This role provides quality oversight of operational activities and ensures the effective implementation, monitoring, and maintenance of a GMP‑compliant quality system, while supporting a reliable radiopharmaceutical supply.

Qualifications

• Master’s degree in a scientific discipline.
• Pharmacy background is preferred.

Responsibilities

• Review and release batch analyses in line with EU and national regulations.
• Provide quality, compliance, and technical expertise for investigations including deviations, CAPAs, changes, and complaints.
• Ensure deviations/complaints with possible impact on patient safety or supply are escalated and resolved.
• Provide quality oversight for site operations, including validation, qualification, equipment, and training.
• Draft, review, and approve GMP documents and Quality Manual updates.
• Act as SME during health authority inspections and audits.
• Support a strong quality culture through coaching, training on cGMP and on-call support.

Skills

GMP knowledge

Fluent English

Proactive ownership

Education

Master’s degree in science

Pharmacy background preferred

Job description

Novartis in the Netherlands seeks a Qualified Person responsible for batch release, ensuring product quality and compliance with applicable regulatory requirements, including cGMP, Dutch legislation, and European regulations.

This role provides quality oversight of operational activities and ensures the effective implementation, monitoring, and maintenance of a GMP‑compliant quality system, while supporting a reliable radiopharmaceutical supply.