Pharmaceutical Qa/Qc Chemist
Toronto, Canada Area
• Performed analysis of Raw materials and finished products according to USP• experience in operation of dissolution apparatus 1 and 2.•Experienced in LOD, Karl-Fischer, Titrations, viscosity and Specific gravity tests.• Performed samples analysis using HPLC, TLC, UV/VIS, and IR.• Performed all lab works according to guidelines of GMP and USP.•Performing analyses on raw materials, finished products, stability products using HPLC, UV/VIS, FT-IR, Dissolution apparatus ,Karl Fischer, TLC, Polari-meter , Viscosity-meter and etc per USP/NF monograph .• Performed physical quality control analysis : Friability, hardness, bulk,tapped density, particle size by Ro-Tap sieve shaker method.• performed all assigned work accordance with the current Good Manufacturing practice (cGMPs), SOPs, GCPs regulatory requirements, best practices and established health and safety standards.•Prepared electronic and paper DMF (drug master file) in CTD format to obtain registration approvals from Health Canada and ANDSs.•validating high-performance liquid chromatographic (HPLC) methods developed for the analysis of pharmaceutical drug substanc•Revising tests and methods for raw material and packaging components as per USP, EP and cGMP requirement.•Oversee the OOS/OOT investigation activities and ensure that processes and documentation are in compliance with regulations, policies, and specifications.•Conduct validation of analytical methods as per ICH guidelines and Standard Operating Procedures (SOPs). •Complete Change Control, CAPA and DEV investigation in collaboration with the fabricators.• Performed USP, EP ,BP and in-house monographs analyses to ensure the quality of the products.• Participate in the facility audit/inspection preparation and provide site training. Act as scribe for client audits and regulatory inspections (FDA and Health Canada). Prepare change controls to implement corrective action plans•Implemented formulation and labeling changes