Salary Range:
€44,100.00 - €81,900.00Job Description Summary
#LI-OnsiteLocation: Baarle Nassau, Netherlands
We are seeking a detail-oriented QA Operations Specialist to join our team. This position supports a 24/7 shift-based operation, so candidates must be comfortable working assigned shifts, which includes days, evenings, nights, weekends, and bank holidays as needed.
The Quality Assurance Operations Specialist provides QA support for all shopfloor GMP related activities. The main focus is linked to the on-time batch release process and all related operational activities to ensure that the batches are released according to regulatory compliance and the local quality system. This ranges from material release and batch record reviews, to deviation support and technical QA support (e.g. calibrations, interventions).
Job Description
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? 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.
Skills Desired
Collaboration, Communication Skills, Data Integrity, Dealing With Ambiguity, Digital saviness, Leadership, Operational Excellence, Problem Solving Skills, Regulatory Requirements knowledgeSkills Required
- Solid knowledge of quality system (GMP) and regulatory requirements
- Education: MBO/HBO level, preferably in a scientific field
- Experience with radiation, PET or radiopharmaceuticals
- Fluent in English, verbally and in writing
- Good organizational skills including attention to details
Novartis Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Novartis and has not been reviewed or approved by Novartis.
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Healthcare Strength — Pay and benefits are described as a strong overall package, supported by medical, dental, and vision insurance alongside FSAs/HSAs and disability and life coverage. Mental-health support is reinforced through an employee assistance program with psychological support and a network of mental health first aiders.
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Retirement Support — Retirement support is positioned as a standout element, with an automatic company contribution plus dollar-for-dollar matching in the 401(k). Additional retirement funding is described through an age-based defined contribution program and access to an employee share purchase plan discount.
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Parental & Family Support — Family-related benefits are framed as robust, including a global minimum of paid parental leave for new parents following birth or adoption. Added supports include domestic partner coverage, dependent-care resources, and benefits such as adoption assistance and child/elder care options.
Novartis Insights
What We Do
Novartis is an innovative medicines company. Every day, working to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 250 million people worldwide.
