About this role
This Research Associate role focuses on analytical support for impurity and nitrosamines synthesis and qualification in the pharmaceutical industry. It requires 2-4 years of experience post-graduation in Chemistry. The position involves method development and routine testing for allotted projects.
Day-to-day tasks include analyzing raw materials, in-process samples, intermediates, and APIs on time. Responsibilities cover qualification of standards, controls, and support for nitrosamine and impurity studies. Daily calibration, document control, and timely query resolution for API projects are essential.
Work in the ARD Lab environment demands adherence to GLP/cGMP norms, good housekeeping, and instrument cleanliness. Support extends to external and internal PD Lab queries. Partial validation, holding studies, DMF queries, and physicochemical studies are performed as needed.
Stability sample analysis follows schedules to ensure compliance. Data integrity and regulatory standards are maintained through complete documentation. This role contributes to project success in a controlled lab setting.
Requirements
- 2-4 years of experience post-graduation in Chemistry
- Experience in analytical method development
- Knowledge of nitrosamine and impurity qualification
- Familiarity with GLP/cGMP compliance
- Proficiency in analytical instrument calibration and maintenance
- Ability to perform partial validation and holding studies
- Skills in physicochemical studies and stability analysis
Responsibilities
- Perform analytical method development and routine analytical support for allotted projects
- Qualify standards and controls for allotted projects
- Support external and internal PD Lab queries
- Provide nitrosamine and impurity qualification support
- Handle daily calibration, document control, and compliance
- Ensure good housekeeping and adherence to GLP/cGMP norms in ARD Lab
- Analyze RM, in-process, intermediates, and API on time
- Develop suitable analytical methods and create STP timely
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