Pharmaceutical Analytical Research and Development

• Maintained and prepared analytical team related documents.• Performed test method transfers, analysis of tablet formulation as per test procedures.• Executed analysis of method development, validation, assay, related substances and dissolution development.• Proven experience and knowledge in residual solvent analysis, content uniformity by GC and HPLC methods.• Worked on deliverable preformulation activities and preformulation activities.• Accomplished analysis of… Show more • Maintained and prepared analytical team related documents.• Performed test method transfers, analysis of tablet formulation as per test procedures.• Executed analysis of method development, validation, assay, related substances and dissolution development.• Proven experience and knowledge in residual solvent analysis, content uniformity by GC and HPLC methods.• Worked on deliverable preformulation activities and preformulation activities.• Accomplished analysis of dissolution comparison (F1 and F2 Comparison) and bio-relevant tests.• Collected data using qualitative and quantitative techniques and write up results.• Ensured strict adherence to the various quality measures by maintenance of appropriate requisite documentation/ records.• Prepared standard testing procedures (STP), general test procedures (GP), analytical documents & their summary reports.• Conducted in-house material testing/ inspection of components.• Actively involved in audits and Training's.• Extensively worked on extended release dosage forms and sustained release dosage forms. Show less

• Maintained and prepared documents such as development report, validation protocol, standard operating procedures (SOP),standard operating procedures (STP) stability reports, analytical results and laboratory notebooks.• Performed analytical method development by using HPLC, UPLC and dissolution.• Conducted analysis of assay, related substances, multi media Dissolution, DSC,and content uniformity, by relevant analytical techniques.• Involved in preformulation activities like… Show more • Maintained and prepared documents such as development report, validation protocol, standard operating procedures (SOP),standard operating procedures (STP) stability reports, analytical results and laboratory notebooks.• Performed analytical method development by using HPLC, UPLC and dissolution.• Conducted analysis of assay, related substances, multi media Dissolution, DSC,and content uniformity, by relevant analytical techniques.• Involved in preformulation activities like excipient compatibility.• Ensured adherence to the various quality measures by maintenance of appropriate requisite documentation/ records.• Performed literature search.• Worked on oral disintegration tablets, capsules, IR tablets, hydroxide gels and chelating projects. Show less

• Prepared Stability reports of analytical results.• Performed the analysis of drug product stability as per STP (assay, related substances, pH , optical rotation, wet analysis, osmolality, water by KF and specific gravity measurement).• Reported and documented the analysed results as per GLP and documentation procedure.• Ensured adherence to the various quality measures by maintenance of appropriate requisite documentation/ records.• Worked on injection and solid dosage… Show more • Prepared Stability reports of analytical results.• Performed the analysis of drug product stability as per STP (assay, related substances, pH , optical rotation, wet analysis, osmolality, water by KF and specific gravity measurement).• Reported and documented the analysed results as per GLP and documentation procedure.• Ensured adherence to the various quality measures by maintenance of appropriate requisite documentation/ records.• Worked on injection and solid dosage forms. Show less