Nitrosamine CoE Expert

Sep 24, 2021

Job Description


- Manages Nitrosamine aspects & projects within area of responsibility.
- Provide technical support and analytical information to the team
- Ensures and supports overall GxP conformity & Compliance with the Novartis Quality Management Systems.

Major Accountabilities

- Oversight of all Nitrosamine activities including method development, method validation and testing of the API or Drug Product batches
- Provide an active organization for all the situations originating from the method, to develop applicable instrumental solutions, and to ensure the implementation
- Life-cycle management of Nitrosamine analytical methods, including control of method performance, pharmacopoeia and health authority compliance and definition of method improvements
- Coordination of functional operational activities in line with Global Nitrosamine Taskforce
- Ensure the analytical methods in validated status and at sustainable performance
- Line responsibility & daily walkthrough
- Investigation of Deviation, OOx, Complaints
- Define and implement CAPAs
- SOP review & revision
- Provide on time data for related Quality escalations, be able to present during the meetings with Global Taskforce or customer sites
- Ensure the Nitrosamine Lab is ready for all inspections and audits

Diversity & Inclusion / EEO

Novartis, olağanüstü, kapsayıcı bir çalışma ortamı ve çeşitli ekibin hizmet verdiğimiz hasta ve toplulukların temsilcisini oluşturmaya kendini adamıştır.

Minimum Requirements

- University degree in Pharmacy, Chemical Engineering or Chemistry
- Minimum 5 years of Analytical Laboratory experience with equipments e.g. LCMS/MS, GCMS/MS, HPLC, GC, preferably at a pharmaceutical company
- Knowledge of cGMP& cGLP and basic SAP
- Ability to work in a fast-paced changing environment
- Team working and customer oriented mindset
- Good analytical thinking skills
- Strong communication skills and leadership presence
- Good knowledge of MS Office applications
- Good command of English is required
Novartis Technical Operations
Tam Zamanlı
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Nitrosamine CoE Expert

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