Posted:2 months ago| Platform:
Work from Office
Full Time
Role & responsibilities Develop and optimize analytical methods for trace level quantification of other impurities in drug substances and products. Validate analytical methods to ensure accuracy and reliability by LCMS. Routine Analytical Method Transfer for Impurity by LCMS/MS. Routine Analysis of Finished goods, RM by LCMS. Routine Analysis of Cleaning Validation Sample by LCMS. Plan, organize, and document scientific experiments according to quality standards. Troubleshoot analytical methods and instrumentation issues. Collaborate with project teams to support project deliverables. Maintain GMP standards in testing and documentation. Implement and maintain lean, efficient, and sustainable practices in the laboratory. Preferred candidate profile Communication Skills: Strong analytical, problem-solving, organizational, and time management skills. Minimum 3 to Maximum 10 Years of experience required Experience: Hands-on experience in API based pharmaceutical analytical methods. Regulatory Knowledge: Familiarity with ICH guidelines, cGMP, and regulatory requirements for analytical testing. Technical Skills: Expertise in trace level quantification techniques such as LC-UV/FID, Ion Chromatography, LC-MS, GC-MS, and high-resolution mass spectrometry.
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