Nitrosamines Specialist (m/f/d) - Kurtköy, Istanbul
Constellation Pharmaceuticals
Band
Level 3
Job Description Summary
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.
Job Description
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
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Join our Novartis Network:
If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Skills Desired
Collaboration, Communication Skills, Data Integrity, Dealing With Ambiguity, Decision Making, Digital saviness, Leadership, Problem Solving Skills, Regulatory Requirements knowledge, Statistics