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Associate qa operations expert - qa release

Puurs
Novartis
Publiée le 4 février
Description de l'offre

Band Level 3 Job Description Summary LI-Hybrid 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 Key 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. Essential Requirements: Master’s degree in a scientific field such as Pharmacy, Industrial Pharmacy, Bio‑engineering, or related discipline. 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. Excellent communication skills with the 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. 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. Skills Desired Collaboration, Communication Skills, Data Integrity, Dealing With Ambiguity, Digital saviness, Leadership, Operational Excellence, Problem Solving Skills, Regulatory Requirements knowledge

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