## [Quality Assurance Operations Specialist](/req-10078604-quality-assurance-operations-specialist "Quality Assurance Operations Specialist") Job ID REQ-10078604 Jun 22, 2026 LOC_NL ### About the Role Please note: This is a 100% on-site position and is not eligible for remote or hybrid work. Candidates must be available to work within a 24/7 shift schedule. Major Accountabilities: - Prepare and perform QA review of batch release documents and supports the Quality Responsible with the batch release process. - On-site Quality support for operational activities including interventions. - Guarantee the correct document lifecycle management (paper and electronic system). Ensures archiving of batch documentation. - Release of starting materials and incoming goods. - Perform Visual Monitoring on Surprise on-site inspections. - Approve and review quality related documentation (operational procedures, protocols, and work instructions). - Supports with deviation management. Ensures that the appropriate impact assessments are performed in a timely matter. Ensures that deviations are closed in a timely matter. - Review and approve the investigations in case of analytical results out of specification (OOS), out of trend (OOT), out of expectation (OOE) or System Suitability Test failures. - Supports with CAPA’s and Actions and timely execution of defined actions. - Supports with change controls and timely execution of defined actions. - Support the preparation and execution of internal audits and Health Authorities inspections ​ Obligatory requirements: ​ - Education: MBO/HBO level, preferably in a scientific field. - Experiences: Solid knowledge of quality system (GMP) and basic knowledge of regulatory requirements. - Strong affinity with and awareness of quality issues. - Good organizational skills including attention to details. - Shows the appropriate sense of urgency around given tasks, work in team. - Languages: English fluently, verbally and in writing. - Work in shifts Desirable requirements: - Optional: Experience with radiation, PET or radiopharmaceuticals is highly valued. ​ 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. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? Benefits and Rewards: Learn about all the ways we’ll help you thrive personally and professionally. ### Role Requirements **Why Novartis:** Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? [https://www.novartis.com/about/strategy/people-and-culture](https://www.novartis.com/about/strategy/people-and-culture "https://www.novartis.com/about/strategy/people-and-culture") **Benefits and Rewards:** Learn about all the ways we’ll help you thrive personally and professionally. [Read our handbook (PDF 30 MB)](https://www.novartis.com/sites/novartis_com/files/novartis-life-handbook.pdf) Primary location salary range €44,100.00 - €81,900.00 Division DIV_TO Business Unit Quality Location LOC_NL Site Baarle Nassau Company / Legal Entity NL42 (FCRS = NL042) IDB Holland BV Functional Area FCT_QA Job Type Full time Employment Type Regular Shift Work No [Apply to Job](https://novartis.wd3.myworkdayjobs.com/en-US/Novartis_Careers/job/Baarle-Nassau/Quality-Assurance-Operations-Specialist_REQ-10078604-1 "Apply to Job") ![careers default image](https://prod1.jobapi.novartis.com.cn/themes/custom/cosmos/patterns/images/careers-default-image.webp "careers default image") Job ID REQ-10078604 ### Quality Assurance Operations Specialist [Apply to Job](https://novartis.wd3.myworkdayjobs.com/en-US/Novartis_Careers/job/Baarle-Nassau/Quality-Assurance-Operations-Specialist_REQ-10078604-1 "Apply to Job")