摘要
We are looking for a highly motivated and skilled Nitrosamines Specialist to join our Analytical Sciences & Technology (AS&T) Hub and Nitrosamines in Istanbul. The candidate will be responsible for managing all analytical activities within the Nitrosamine laboratory in compliance with GxP, including method development, validation, and transfer studies using LC-MS/MS, GC-MSMS and HR-MS. This role requires strong technical expertise, meticulous documentation skills, and adherence to quality and data integrity standards (ALCOA+). The candidate will work collaboratively with cross-functional teams, support audit readiness, and contribute to continuous improvement initiatives while ensuring compliance with Novartis Quality Management Systems.
About the Role
Major accountabilities:
- Management of all analytical processes in the Nitrosamine laboratory in accordance with GXP
- Completion of assigned responsibilities correctly the first time, in accordance with relevant procedures (SOP, GOP, etc.) and workflows
- Execution and documentation of analytical method validation, analytical method transfer, and method development studies planned under the responsibility of Nitrosamine department
- Unexpected situations experienced during analytical studies are recorded and carried out in accordance with the relevant SOP within the scope of OOX- Deviation- TTI
- Preparation of all documents prepared after analytical studies (worksheet, FRM, analytical report, etc.)
- Preparation of documents related to the license
- Ensuring and maintaining the general order of the laboratory
- Using the devices in the laboratory in accordance with the operating instructions
- Compliance with HSE rules required in the laboratory
- Execution of laboratory operation in line with data integrity (ALCOA+) rules
- Self-sacrificing follow-up and implementation of delegated responsibilities within the team
- Updating and reviewing department procedures
- Taking responsibility for pre-audit preparations and subsequent actions
- Taking necessary actions in escalation processes
Key performance indicators:
- Quality oversight and timely execution of all analytical tasks under Nitrosamine scope
- Full compliance with GxP and Novartis Quality Management Systems
- Effective communication and collaboration with stakeholders
- Documentation and audit readiness at all times
Essential Requirements:
- University degree in Chemistry, Chemical Engineering, Pharmacy or related scientific fields
- Minimum 4 years of experience in analytical development or quality control in the pharmaceutical industry
- Proven experience in LC-MS/MS method development, validation, and feasibility testing – preferably with Nitrosamine studies
- Sound knowledge of mass spectrometry, GLP/GMP practices, and regulatory expectations
- Communication Skills
- Continuous Learning
- Dealing With Ambiguity
- Decision Making Skills
- Gxp
- Industry Standards
- Laboratory Equipment
- Laboratory Excellence
- Quality Control (Qc) Testing
- Quality Control Sampling
- Technological Expertise
- Total Quality Management
- English
Why Novartis?
Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture
Benefits and Rewards:
Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: Novartis Life Handbook
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
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
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Innovative Medicines
TR01 (FCRS = TR001) Novartis Sağlık, Gıda ve Tarım Ürünleri San. Ve Tic. A.Ş.
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Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
