Description
SUMMARY OF QUALIFICATIONS Quality Systems - Quality Control /Quality Assurance Management of Analytical Laboratories/Quality Audits/Scientific Technical Services Liaison Highly motivated, key contributor in Quality Management and cGMP compliance with more than twenty five years of demonstrated growth and success in scientific applications with Contract Manufacturing Organizations in Quality, R&D and manufacturing. Recognized for leadership, creativity, and problem-solving skills. * Experience and knowledge of CFR Title 21, Parts 210 and 211 and ICH Guidelines. * Experienced in collaborative management with internal and external customers from a scientific, project management and business perspective. * Thorough understanding of USP-NF and Ph. Eur. compendia. Solids, Creams. Liquids, Ointments and Gels. * Participated in NDA submissions to the FDA and EMEA. Participated in FDA general inspections, preapproval inspections, and client audits ensured compliance to cGMP's. Responsible for all QC laboratory investigations external and internal. Over seven years specifically with CMO's * Author, reviewer and or approver for investigations and CAPA's pertaining to raw materials, bulk and packaged product as well as cleaning and process validation. * Author, reviewer and or approver for SOP's, change control, deviations, and incident reports for all laboratory operations and review of the same for manufacturing as appropriate. * Review and approval for all APR's at the manufacturing sites. * Proven quality resource for manufacturing and technical environments. Broad-based knowledge of instrumental analysis and laboratory operations.
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