Job Summary

Brief team/department description:

The analytical team at R&D; is playing an key role in product development of various dosage forms. The analytical team involves different workflows like analytical method development, stability studies, involving method verifications at CMO/CTL and post filling activities.

This role is with Azurity R&D; Analytical Scientist, which required to work in product development team s analytical method development, Formulation sample analysis, method verification, Compendial method evaluation, Stability sample analysis and instruments calibrations.

Principle Responsibilities
Follow Positive documentation practices
Execution of analytical method development of Nitrosamine impurities using high end instrument and method validation parameters for developed method.
Execution of analytical method development for unknown impurity and Genotoxic impurity identification using HPLC-PDA/UV/ELSD and LCMS techniques.
Ensuring all documents and data for adequacy, accuracy, and completeness during the execution and documentation.
Execution of Formulation developmental samples analysis as per ATR, recording of online documentation and completion of the analysis on time.
Adhere to current GLP procedure,



data integrity and meeting SOP compliance requirements.
Development of Analytical methods using different analytical techniques, method verification of compendial methods, verification of Drug substance test methods.
Follow the safety procedure in the laboratory.
Should have exposure in preparing the STP, MDR, MOA for the allocated products.

Qualifications and Education Requirements
Postgraduate in Pharmacy or Science.
minimum 3 years of experience in pharmaceutical analytical R&D; handling of LCMS instrument under this category.
Well versed with analytical method development of Nitrosamine impurities in DS, DP and Excipients.
Knowledge of unknown impurity identification using LCMS technique in DS, DP in Pharmaceutical Research and Development.
Understating Positive Laboratory Practices and Good Document Practices.
Should have knowledge /exposure to electronic eLN/DMS systems.
Proficient in written and spoken English.

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📌 Analytical Scientist/ Scientist Hyderabad
🏢 Azurity Pharmaceuticals
📍 Hyderabad