• Review lab analysis data and Empower audit trail electronic data for completeness, specification compliance with cGMP, USFDA/Health Canada and compliance with company’s written SOP• Report any abnormal findings to the QC/QA manager. As assigned, perform in-depth review of analytical records/reports to assure that calculations and analytical raw data / electronic data are technically correct and compliance • Perform document review of different raw materials/API’S, Finished products… Show more • Review lab analysis data and Empower audit trail electronic data for completeness, specification compliance with cGMP, USFDA/Health Canada and compliance with company’s written SOP• Report any abnormal findings to the QC/QA manager. As assigned, perform in-depth review of analytical records/reports to assure that calculations and analytical raw data / electronic data are technically correct and compliance • Perform document review of different raw materials/API’S, Finished products and stability samples, R&D projects data as per current USP/EP, client methods or compendial methods• Provide timely authorization of release samples in LIMS and review the draft COA to ensure that completed information and data are printed, no out-of-spec limit data observed, COA submit to different clients• Communicate with QC/QA Manager and 3rd party clients for any delay project due to OOS/Deviation results • Work as an effective team member to meet departmental goals and TAT of client’s sample submission result, sharing knowledge with team members• Daily performed Balances, pH meter and Milli Q Water verification, Monthly internal lab audit and Analyst /Instruments logbooks audit with QA manager Show less

• Perform analysis of different raw materials/API’S and Finished products as per current USP/EP or compendial methods in Product Life Cycle Management department• Perform testing for release and stability samples in accordance with established method, specification and protocol using different instruments in support of commercial products• Peer review, approve controlled documents and records, coordinate with other department for past data regarding of Stage II and stage III… Show more • Perform analysis of different raw materials/API’S and Finished products as per current USP/EP or compendial methods in Product Life Cycle Management department• Perform testing for release and stability samples in accordance with established method, specification and protocol using different instruments in support of commercial products• Peer review, approve controlled documents and records, coordinate with other department for past data regarding of Stage II and stage III Investigation of QC department• Assist in writing and reviewing of laboratory investigations, coordinate with scientific leader • Strong knowledge of current GMP, GLP,SOP and laboratory health and safe work practices Show less

• Analyze purity and impurity profile of API by using HPLC and wet chemistry techniques• Perform reference standard qualification, check potency ,% assay, water content of different raw materials ,ID test by IR or by HPLC or by UV• Extensive and comprehensive knowledge of system suitability parameters, operational qualification and data acceptance criteria based on method and cGMP regulations• Comprehensive knowledge and experience in generate and maintain Out Of… Show more • Analyze purity and impurity profile of API by using HPLC and wet chemistry techniques• Perform reference standard qualification, check potency ,% assay, water content of different raw materials ,ID test by IR or by HPLC or by UV• Extensive and comprehensive knowledge of system suitability parameters, operational qualification and data acceptance criteria based on method and cGMP regulations• Comprehensive knowledge and experience in generate and maintain Out Of Specification(OOS),Peer review data and investigation of any deviation or OOS data ,root cause analysis and CAPA Show less

• Independent execution and troubleshooting of analytical activities including stability studies, method development and method validations• Prepared standard solution , stock solution and different concentration mobile phase of HPLC• Perform quantitative and qualitative analysis of raw materials, intermediate, finished products as per USP• Performs additional related duties, as assigned, in accordance with job responsibilities and necessary departmental objectives• Conduct all… Show more • Independent execution and troubleshooting of analytical activities including stability studies, method development and method validations• Prepared standard solution , stock solution and different concentration mobile phase of HPLC• Perform quantitative and qualitative analysis of raw materials, intermediate, finished products as per USP• Performs additional related duties, as assigned, in accordance with job responsibilities and necessary departmental objectives• Conduct all assigned work in a good team environment and focusing on meets project time deadline of clients Show less

• Prepare sample labels according to testing and entered in to in house Lab software• Perform different kind of organic extraction tests of environment lab water, soil and oil sample in a timely manner. Keep holding time and effective time management when prioritizing work• Extensive knowledge of organic chemical synthesis and chemical reactions• Organize and maintain lab supplies in collaboration with other members of the laboratory group• Perform all work in support of… Show more • Prepare sample labels according to testing and entered in to in house Lab software• Perform different kind of organic extraction tests of environment lab water, soil and oil sample in a timely manner. Keep holding time and effective time management when prioritizing work• Extensive knowledge of organic chemical synthesis and chemical reactions• Organize and maintain lab supplies in collaboration with other members of the laboratory group• Perform all work in support of Corporate Values of Pride, Accountability, Integrity and Diligence Show less

• Perform quantitative and qualitative analysis of intermediate of 7ACCA / 7 ADCA Anti TB finished product as per compendial methods ,Compiling data and interact with QA team for any result queries • Perform API testing of intermediate reaction monitoring, communicate and coordinate with production team• Analyze API testing and solve quality issues of product concerning with senior Lab management• Work as an effective team member to meet departmental goals, sharing knowledge with… Show more • Perform quantitative and qualitative analysis of intermediate of 7ACCA / 7 ADCA Anti TB finished product as per compendial methods ,Compiling data and interact with QA team for any result queries • Perform API testing of intermediate reaction monitoring, communicate and coordinate with production team• Analyze API testing and solve quality issues of product concerning with senior Lab management• Work as an effective team member to meet departmental goals, sharing knowledge with team members Show less