Nitrosamines Specialist
Novartis is an innovative medicines company. Every day, we work 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.
The Technology and User Services (TUS) group in NX is driven to help users use tools effectively to improve productivity and foster innovation. We deliver the Technology and User Services (TUS) group in NX to help customers use tools effectively to improve productivity and foster innovation. Our organization is here providing the technology backbone and devices that enable users to work in an office, lab or mobile environment.
Nitrosamines Specialist
We are looking for a highly motivated and skilled Nitrosamines Specialist for our site in Kurtköy. In this role, you will manage analytical activities in the Nitrosamine laboratory in compliance with GxP, including method development, validation, and transfer using LC‑MS/MS, GC‑MS/MS, and HR‑MS. You will ensure high‑quality documentation and data integrity (ALCOA+), collaborate closely with cross‑functional teams, support audit readiness, and contribute to continuous improvement while adhering to Novartis Quality Management Systems.
About the Role
Major Accountabilities:
- Manage all analytical activities in the Nitrosamine laboratory in compliance with GxP and Novartis procedures.
- Execute and document method development, validation, and transfer studies in line with approved SOPs and workflows.
- Ensure accurate, complete, and compliant documentation (e.g. worksheets, reports, license‑related documents) following data integrity principles (ALCOA+).
- Handle deviations, OOX, and unexpected events according to defined procedures and escalation processes.
- Maintain laboratory order, equipment usage, and full compliance with HSE requirements.
- Support audit readiness, pre‑audit preparations, and follow‑up actions.
- Continuously review and update departmental procedures and contribute to team responsibilities and continuous improvement initiatives.
Essential Requirements:
- Degree in Chemistry, Chemical Engineering, Pharmacy, or a related field
- 4+ years of experience in analytical development or QC within the pharmaceutical industry
- Hands‑on expertise with LC‑MS/MS and GC‑MS/MS (nitrosamines experience is a strong plus)
- Solid understanding of mass spectrometry, GLP/GMP, and regulatory requirements
- Strong communication skills and a continuous learning mindset
