Dr.Reddys Laboratories
Function : Analytical R&D
Functional Area : Nasal and Inhalation Division
Job Role Summary : Developing, validating the analytical methods and evaluation of sameness studies for Nasal and Inhalation products
Job Profile :
- Develop, validate, and transfer analytical methods for Nasal and Inhalation products, including spray characterization techniques (SP, PG, DSD) and inhalation-specific techniques (APSD, DDU, Pump Delivery) along with assay and impurity methods .
- Perform Drug Master File/Literature review, procure relevant materials, and stay updated with industry developments.
- Execute analytical activities as per defined procedures, document data.
- Conduct method validation studies and transfer validated methods to Quality Control (QC) department/
- Ensure proper maintenance, calibration, and operation of laboratory equipment in compliance with Good Laboratory Practices (GLP) standards.
- Maintain accurate documentation, organize work area, and adhere to Standard Operating Procedures (SOPs) to ensure compliance with internal and external auditing requirements.
Job Requirements :
- Should be well versed with the planning and conducting experiments for the PoP BE/sameness studies
- Have work experience on Analytical Development, Method Validation, Sameness studies etc in inhalation/injectable dosage form
- Exposure to Formulation Development and expertise in inhalation/injectable dosage form.
- Understanding on Abbreviated New Drug Application (ANDA) filing requirements.
- Strong understanding of regulatory guidelines and industry standards related to pharmaceutical product development and analysis.
Work / Job Experience : 7-10 Years
Type of Experience : Analytical method development, validation and sameness studies.
Academic Qualifications :
Masters in Science/ Organic chemistry/ Pharmaceutical Sciences
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