Description
Life cycle Management and documentation of specification in Laboratory Information Management Systems (LabWare LIMS) in cGMP environment. * Create and Manage Drug substance, Drug product, and Raw materials specifications in LIMS against the master specification copy available in the Document management system. * Accurately configure Analysis's including Strength, Impurities content, Water content, Content uniformity, Residual solvents, Microbiological Examination etc., in LIMS as per United States Pharmacopeia (USP), European Union Pharmacopeia (EU) and Japan Pharmacopeia (JP). * Collaborate with stakeholders such as Regulatory Affairs, Analytical Operation groups, Commercial Manufacturing and Quality Assurance to complete documentation on specification change requests and ensure the data changed captured properly. * Ensure that master and reference data in LIMS is adhering to the Clients Standard Operating Procedures (SOP's), Work Instructions (WI) and managed in accurate, complete and timely manner. Data includes specification and methods in LIMS, test methods in the Lab Execution System and templates in Empower chromatography data acquisition. * Management of Static data like configuring Stability Protocols, Stability Specification, and generate Stability Summary Reports (SSR's) in LIMS. * Create stability study protocols and interpret test results, compare them to specifications in LIMS and control limits, and make recommendations on data accuracy of specifications In LIMS. * Review and interpret High Pressure Liquid Chromatography (HPLC), and Gas Chromatography (GC) Global Test methods (TM), and Test method Addendum (TMA) documents. * Review and interpret Analytical method validation documents (HPLC and GC). * Investigate and collaborate with stakeholders on specification/Test method/Analytical method Validation report, change request and validate & Update the analysis. * Experience in working with stakeholders for calibrating, validating and mapping of products between previous LIMS and the next version of LIMS. * Collaborate with LIMS Developers in providing inputs for the LIMS modules Configured, developed and maintained for the enhancement of the LIMS systems. * Experienced in performing Dry run of User Acceptance Testing (UAT) scripts validated by the Validation Groups and developed by LIMS developers. * Provide training and support to stakeholders in using LIMS. * Performs periodic Audit trail reviews in LIMS. * Experienced in participating Internal GMP audits. * Experience in HPLC method development and validation for pharmaceuticals, developing new analytical test procedures to support the R&D. * Service-oriented person with proven ability to manage timely assigned tasks. * Excellent communication, oral and written skills, ability to work as an individual and as a part of a team with problem solving skills.
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