20 Sep
|
SDP HR Solution
|
Bharuch
20 Sep
SDP HR Solution
Bharuch
:
Analytical Method Development: Develop, optimize, and troubleshoot analytical methods for assay, dissolution, related substances/impurities, and residual solvents.
Method Validation: Execute analytical method validation as per ICH guidelines, including accuracy, precision, specificity, linearity, range, robustness, and system suitability.
Instrument Operation: Hands-on experience with HPLC, GC, UV-Vis, FTIR, and Karl Fischer titrators, including instrument troubleshooting and data interpretation.
Stability Studies: Perform analysis of stability samples and evaluate analytical results to support shelf-life determination and recommended storage conditions.
Documentation & Compliance: Maintain complete raw data, analytical records, protocols, reports, and validation documentation in compliance with GLP, cGMP, and data-integrity requirements.
Cross-Functional Collaboration: Coordinate with QC, QA, R&D;, Production, and Regulatory Affairs teams to support formulation development, technology transfer, investigations, and regulatory submissions.
📌 Analyst Research & Development Bharuch
🏢 SDP HR Solution
📍 Bharuch