Lifelancer
Location
Thane | India
Job description
About the job
Job Title : Senior Scientist Nitrosamine Testing Analytical Research and Development
Job Location : Thane
Experience : 4+ Years
Qualifications : M.sc Chemistry /M.Pharmaceutical Analysis
Function : Nitrosamine Testing
Department : Analytical Research Development
Job Responsibilities
Proficiency in LC-MS techniques including calibration, mass tuning and software handling especially with advanced triple quad mass spectrometry.
To perform Method development and validation of nitrosamines impurities for drug products in line with global regulatory guidelines on LC-MS/MS instrument with independence and efficiency in compliance.
Responsible for writing of protocol, report and compilation of data generated during nitrosamine testing of drug product.
Demonstrate competency in optimization of critical and challenging nitrosamine assays.
Well versed with latest nitrosamine guidelines across the health authorities.
Display advanced data interpretation and analytical instrumentation skills.
Familiarity with unknown impurity identification and profiling studies.
Responsible for responding technical and quality related queries of regulatory agency.
Daily operation and support of LC-MS systems in the lab.
Performing general troubleshooting and maintenance of LC-MS instrument.
Evaluating and solving analytical problems related to off-trend results observed during testing.
Active participation in process improvement initiatives.
Proven ability to prioritize and demonstrate advanced time management on multiple assigned work.
Ensuring study objectives are met within the defined project timelines.
To communicate with Engineering team and Instrument Service engineers for Breakdown related activities.
Responsible for procurement of Columns, Impurities, Reagents, Chemicals required to conduct nitrosamine analysis.
Ability to work on assigned variety of products.
Ability to work collaboratively within a team and communicate effectively.
To Calibrate the instruments and Equipment as per Calibration schedule
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