Description
Summary * Experienced Quality Assurance scientist in the pharmaceutical and biotechnology industry working for over 17 years in a cGMP and GLP regulated environment. * Lead efforts in the business analysis for the group's business continuity program and the implementation of the Laboratory Information Management Systems (LIMS). * Knowledgeable in Project Management methodologies like 5S, LEAN and Six Sigma. * Skilled in analytical methods transfer, instrument usage, and method validations while following ICH, FDA and multi-compendial (USP, EP and JP) guidelines for raw materials and finished products. * Ensured that all generated laboratory documentation, either by our internal or external laboratories, was performed within compliance with the established SOPs, cGMP with strict adherence to FDA compliance guidelines. * Knowledgeable in analytical laboratory methods including HPLC (Waters, HP 1100), GC (Agilent), UV/VIS, and dissolution.
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