NovartisQuality Assurance Operations Specialist
AI in this role
Salary Range:
€44,100.00 - €81,900.00
Job 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 knowledgeHow we score this
Quality Assurance Operations Specialist at Novartis scores 38 out of 100 on AI centrality, which makes it AI Level 1 of 4 (Little AI) on this board. The level measures how much of the work is AI, not seniority.
AI Level 1. The work itself involves no AI, or AI only appears as scenery, such as a company tagline.
- AI Level 480 to 100
- AI Level 360 to 79
- AI Level 240 to 59
- AI Level 10 to 39
Bands come from how often the tools, models and workflows of the role are named in the posting itself. Open the description and count.
Get new AI jobs by email
One email a week with the new AI jobs, each rated AI Level 1 to 4 for how much AI is in the work. No recruiter spam, unsubscribe in one click.
Free. One email a week. Unsubscribe in one click.
Similar roles
Software Engineering roles rated AI Level 1 at other companies.
What kind of AI work fits you?
Answer 12 practical questions in about three minutes. Get a simple profile, the work it points to, and live roles to explore next.
Find my next step