• Instrumental in Method Development, Validations as per ICH Q2(R1) guidelines and stability studies for China and Hong Kong market.• Accountable for Technology transfers at plant location• Troubleshooting of Methods for ongoing QC products • GLP compliance• Build up the Internal SOP system for the department by drafting and implementing many important SOP’s as per department’s requirements.• Providing internal development support for manufacturing, process Validation, Quality Assurance/Control• Exceptional knowledge in analytical and creative problem solving • Providing technical and functional assistance to the team • Respond to DRA queries and generate the data required for filing the product for DH, Hong Kong and SFDA, China.• Co-ordinate with other departments like PR, DRA, QC to facilitate the registration process• Maintain compliance with in the department and conducting compliance related trainings on regular basis• Act as the Laboratory Administrator and decision maker in equipment’s purchase, Validations, Maintenance etc. and to address any issues from finance regarding fixed assets. • Responsible for successful implementation of 5S and TPM in Lab and maintain the 5S practices.

• Instrumental in analysis of sample• Accountable for Technology transfers at plant location• GLP compliance and co-ordination with CQA (Corporate quality assurance)• Managing chemicals and solvents inventory for the whole department• Providing internal development support for manufacturing, process Validation, Quality Assurance/Control• Responsible for analytical test methods development, qualification, validation and transfer• Involved in the characterization of drug substance and drug product impurity• Exceptional knowledge in analytical and creative problem solving • Providing technical and functional assistance to the team • Coordinating with team and providing with the updates of activity reports to the Group Leader• Analytical method developments on HPLC with PDA/Dual wavelength detectors, related substances, Diluent compatibility studies etc. of various dosage forms including oral parenterals, Inhalers and of APIs• Analytical method validations on HPLC with PDA detectors for assay, related substances, Diluent compatibility studies in accordance to ICH Q2 (R1), USP guidelines• Routine analysis for assay, blend uniformity, related substances, diluent compatibility studies, chromatographic purity, UV characterization, dissolution (USP-I&II), Wet Analysis etc. of various pharmaceuticals• Validation and development documentation, STP and method transfer sheet generation, data auditing and filing etc.• Calibration of HPLC, UV-Visible Spectrophotometer, analytical balance, micro analytical balance, dissolution apparatus etc.• Technology transfer of ANDA’s for US market at plant location• Respond to DRA queries and generate the data required for filing the product• Method development and Analysis of inhalers ( Both MDI,s and DPI,s), nasal sprays, Topical spraysFollowing tests were performed:• UODD• DEOD• Assay• Related Substances• Cascade Analysis• Average Leak rate• Total Can Assay