QA Operations Specialist Pharmaceutical Release & Compliance

Novartis; Puurs-Sint-Amands; On-site; EUR 47,000 - 88,000; Full time

Benefits offered by this job

Hybrid work options

14 weeks paid parental leave

Insurance and retirement benefits

Job summary

Novartis Puurs site seeks a QA Release Specialist to ensure the timely and compliant release of batch materials, packaging, and imports. You’ll apply QA expertise to investigations, CAPAs, and audits while collaborating with production, QC, MS&T, and supply chain teams.

The role requires a Master’s degree in a scientific field, GMP knowledge, and strong English/Dutch communication. Hybrid work options and competitive benefits are provided.

Qualifications

• Master's degree in a scientific field such as Pharmacy, Industrial Pharmacy, Bio‑engineering, or related discipline.
• Experience within the pharmaceutical industry.
• Strong understanding of GMP and relevant pharmaceutical legislation.
• Proficiency in computer systems with the ability to work accurately with digital documentation.
• Excellent communication skills in English and Dutch, across teams and with external partners.

Responsibilities

• Ensure compliant and timely release of raw materials, bulk products, packaged goods, sterilizations, and imported batches.
• Maintain up‑to‑date expertise in production, sterilization, and release processes relevant to assigned responsibilities.
• Review and assess non‑conformities, support investigations, and define effective CAPAs.
• Contribute to initiatives that reduce deviations and strengthen overall process robustness.
• Monitor file and batch status versus targets and follow up on problem or priority lots.
• Communicate effectively with logistics teams, QC laboratories, and external partners on release‑related matters.
• Provide clear explanations of QA release documentation during internal and external audits.
• Keep assigned procedures accurate, updated, and aligned with evolving operational requirements.

Skills

Collaboration

Communication

Data Integrity

GMP

Internal Quality Auditing

Regulatory Compliance

Quality Management Systems

SOP

QA

QC

Statistical Process Control

Education

Master's degree in a scientific field

Tools

Computer systems

Job description

Novartis Puurs site seeks a QA Release Specialist to ensure the timely and compliant release of batch materials, packaging, and imports. You’ll apply QA expertise to investigations, CAPAs, and audits while collaborating with production, QC, MS&T, and supply chain teams.

The role requires a Master’s degree in a scientific field, GMP knowledge, and strong English/Dutch communication. Hybrid work options and competitive benefits are provided.