Sentiss Pharma Pvt. Ltd.
Website:
sentisspharma.com
Job details:
Job Description:
- Develop and validate analytical methods for testing of product formulations, finished products, raw materials, and APIs using techniques such as HPLC/UPLC/UV/GC/IC, Dissolution, Particle Size Analyzer, Zetasizer, Viscosity, Surface Tension, and wet chemical methods.
- Prepare method development reports from developmental trials, method validation/verification protocols and reports, Specifications, STPs, and Certificates of Analysis from routine analysis and vendor documents.
- Perform analysis of raw materials, APIs, and excipients as per Pharmacopoeial/vendor methods, including analysis of routine and stress samples of finished products.
- Prepare method transfer sheets and transfer analytical methods to plant QC.
- Coordinate outside analysis related to Q3 studies such as XRD, Raman, DSC, TGA, SEM, TEM, etc.
- Review drug substance DMFs and conduct literature searches to support method development.
- Prepare and periodically update relevant SOPs; perform calibration and maintenance of analytical instruments in the laboratory.
- Follow good documentation practices and perform all analytical activities in compliance with cGLP.
- Handle any other responsibilities assigned as required.
Experience Required: 3–10 years
(Designation will be offered based on candidate's experience and skill set)
Qualification Required - M.Sc (Analytical/Chemistry)
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