Description
SUMMARY OF FUNCTIONAL EXPERIENCE AT AKORN: Hands-on experience with pharmaceutical analysis using HPLC, GC/HS, Spectroscopy, physical and wet chemistry. Familiarity with Analytical Chromatography software Backman Peak-Pro, Perkin Elmer TotalChrom and recently implemented Thermo Fisher Chromeleon. Trackwise software for OOS, OOT and deviation investigation. iStability software for stability monitoring and trending. * Quality Control Laboratory Function: * Schedule raw material, in-process, finished goods and stability testing including wet chemistry. * Approve COAs of raw material and finished products. * Instrument calibration and preventive maintenance as per schedule. * Work with analysts troubleshoot instrument and analytical methods. * LIMS - Trackwise module used for tracking OOS, OOT and laboratory deviations. * LIMS - iStability module for stability testing schedule, data entries and product trending analysis. * Assure Quality Control follows FDA and ICH requirements and operates under cGMP requirements. * Prepare protocols and reports for raw material and product analytical method validation/verification to align with current USP monographs and vendors test procedures. * Present lab metrics to the management of releases, backlog, instrument down time, stability testing and OOS/OOT. * Laboratory Personnel: * Work with a team of twenty (20) laboratory personnel including two supervisors. * Conduct weekly laboratory GMP communication meetings to discuss analytical issues, revision of analytical methods and SOPs. * Employees' annual performance reviews, define performance goals, motivate, reward lab personnel for outstanding job and assign Performance Improvement Plan (PIP) for under performer. * Provide training to new employees and execute on-the-job training for current employees for current and new projects. * Regulatory: * Tabulate stability data and perform trending analysis for annual submission (APR) of ANDA products. * Liaison during clients and FDA GMP audits, Preapproval Inspection (PAI) of ANDA products. * Documents & Investigation Reports: * Prepare or review laboratory deviations, Out-of-Specification (OOS) and Out-of-Trend (OOT) investigation reports. * Issue CAPA as required and assure CAPA are implemented in timely manner. * Prepare new and revise Quality Control SOPs, analytical methods, instrument operating and calibration documents to meet current process and procedures. * Cross Functional Support (Manufacturing, R&D, QA, and Contract Labs): * Technical support to Manufacturing Department for questionable in-process and finished product results. * Analytical support to Product Development (R&D) for developed and under development products. * Work with Quality Assurance (QA) for batch record reviews, manufacturing investigations, manufacturing schedule requirements and new product transfers.
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