Associate QA Operations Expert - Release

Novartis; Puurs; Sur place; EUR 47 000 - 88 000; Plein temps

Résumé du poste

Novartis in Puurs, Belgium, seeks a QA Release Specialist to ensure compliant and timely release of materials and finished products. You will apply QA expertise to assess quality, support investigations, and maintain processes across QA, production, QC, MS&T, and supply chain. Strong GMP knowledge and English/Dutch communication are essential.

The role emphasizes CAPAs, audits, and continuous improvement to uphold quality standards and supply reliability for medicines.

Qualifications

• Master's degree in a scientific field (pharmacy, industrial pharmacy, bio-engineering, or related).
• Experience in the pharmaceutical industry.
• Strong understanding of GMP and relevant pharma legislation.
• Proficiency with computerized systems and digital documentation.
• Excellent English and Dutch communication; cross-functional collaboration.

Responsabilités

• Ensure compliant and timely release of materials and products.
• Maintain up-to-date expertise in production and release processes.
• Review non-conformities, support investigations, define CAPAs.
• Contribute to initiatives reducing deviations and improving robustness.
• Monitor file/batch status and liaise with logistics and QA partners.
• Explain QA release docs during audits.
• Keep procedures accurate and aligned with requirements.

Connaissances

Excellent English & Dutch comm.

Pharma industry experience

GMP knowledge

Digital documentation proficiency

Formation

Master's degree in Pharmacy/related field

Description du poste

Salary Range: €47,100.00 - €87,500.00

Job Description Summary

Location: Puurs, Belgium

Relocation Support: This role is based in Puurs, Belgium. Novartis is unable to offer relocation support: please only apply if accessible.

Join a team where your work directly ensures the timely and compliant release of high-quality products to patients. In this position, you'll apply your QA expertise to assess quality and compliance, support investigations and keep essential processes running smoothly. You'll collaborate closely with production teams, QC laboratories, other QA departments, MS&T, Supply Chain and external partners to resolve issues, reduce deviations and strengthen supply reliability. Your contributions to audits, CAPAs, and continuous improvement will uphold quality standards and make a meaningful impact across our operations and for the people relying on our medicines.

Job Description

Major accountabilities:

• 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.

Essential Requirements

• 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 Good Manufacturing Practices and relevant pharmaceutical legislation.
• Proficiency in computer systems with the ability to work accurately with digital documentation.
• Excellent communication skills both in English and Dutch. Ability to collaborate effectively across teams and with external partners.

Desirable Requirements

• Ability or prior experience to act as a Qualified Person (QP) in accordance with applicable regulatory requirements.

Expected Annual Base Salary Range

47.100 - 87.500 EUR.

The base salary offered is determined based on gender-neutral objectives, such as relevant skills, competencies and experience in accordance with the Novartis pay setting policy and upon joining Novartis will be reviewed periodically.

Benefits and Rewards

The rewards of being part of our team go far beyond base pay and incentives. We also offer a variety of competitive benefits in kind to help you thrive personally and professionally, such as insurance plans, retirement plans, wellbeing resources and global recognition programs. In addition, we provide flexible and hybrid working options, where possible, and minimum 14 weeks paid parental leave.

Commitment to Diversity and Inclusion

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

At Novartis

At Novartis, we're committed to reimagining medicine together- and rewarding the people who make it happen.

Skills Desired

• Collaboration
• Communication
• Data Integrity
• Good Manufacturing Practices (GMP)
• Internal Quality Auditing
• Managing Ambiguity
• Operational Excellence
• Quality Assurance (QA)
• Quality Compliance
• Quality Control (QC)
• Quality Management Systems (QMS)
• Regulatory Compliance
• Standard Operating Procedure (SOP)
• Statistical Process Control (SPC)