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Teva Analytical Researcher II India, Maharashtra 351507257
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The opportunity
To support the Global R&D sites for Nitrosamines related Projects
Executing the routine analytical activities such as Method Development, Method validation and Method Transfer activities related to Nitrosamines Impurities and other various tests for API, intermediate products and finished products R&D samples under the guidance of supervisor.
How you’ll spend your day
- To execute the daily analytical work based on allocation and priorities related to the Nitrosamines impurities in an effective manner based on the given timeline.
- Handling and reconciliation of Global analytical samples received from In-house FRD & different Teva Sites.
- Compilation of analytical data generated in the laboratory data strictly adhering to the Quality compliance and in accordance with GLP.
- Support the team in maintaining the prerequisites for Laboratory such as Column, Standards, Chemicals, Spares and Consumables etc.
- To ensure that all activities undertaken are executed in the framework of GLP practices as well as good documentation practices and the existing quality systems are adhered to.
- Support in preparing various Laboratory Documentations such as STPs and analytical related SOPs etc.
- Trouble shooting of analytical instruments for difficulties faced during day-to-day operations.
- Executing the daily Instrument calibration activities
- Laboratory compliance and data integrity during day-to-day operations.
- Actively participate in the implementation of EHS system/Policy. To ensure safe practices are follow during the execution of analytical activities and strict adherence to the EHS systems of the site.
- Literature Search for development of analytical methods
Your experience and qualifications
- MSc./M. Pharm/ Analytical Chemistry
- Masters with 6-9 years relevant experience OR Ph.D. with 3-6 years relevant experienceinAnalytical Chemistry especially in Analytical method Development & Validation for Nitrosamine Impurities in Drug Substance and Drug Product and logical approach.
- Hands on experience on advance Mass technology such as LCMSMS, GCMSMS, LC-HRMS etc.
- Knowledge of regulatory requirements for different markets (US, EU, Canada etc.)
- Sound knowledge of pharmaceutical Quality System, ICH guidelines etc.
Personal attributes
- Basic communication skills and ability to work in a matrix structure
- Must be honest and trustworthy
- Be respectful, Possess cultural awareness and self-motivated.
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