Articulate global/ divisional/Network vision, ensure quality of SDLC and QA projects including Validation, Governance, Compliance, Risk Management, Records Management, Decommissioning; Develop and execute SDLC deliverables (IQ/OQ/PQ/Test Protocols/RA/Trace Matrix/SOP’s); Maintain quality systems (Change Control, Deviations, CAPA, Stability Samples, Document Control) and ensure in compliance with global regulatory bodies (FDA/HPB/ICH); Provide technical support to quality programs like training, records management, sample management, risk management and mitigation; Sustain quality metrics to monitor performance and compliance; Develop, review, execute validation standards and SDLC deliverables as per cGMP regulations; Provide On-Site assessments, audits, risk analysis, client interviews; Improve R&D manufacturing, packaging, enterprise processes and IT systems using benchmark technologies and FDA regulations; Plan and execute manufacturing and packaging projects involving validation, commissioning, qualification, operation, testing, engineering or design.
Proficiency in cGMP data migration and archive strategies for Beckman LIMS, SQL LIMS, Cerity, Empower, NuGenesis, Ti-net, Tiamo, CyberLab, CCMA, TrackWise, SAP, Maximo, Data3, DCS, BAS required. Validation and Decommissioning plans for manufacturing and packaging (Liquids/tablets) equipment, ERP systems (SAP/Maximo); and qc lab equipment (HPLC, GC, CE, AAS, FTIR, PKS, Biolog, X-Ray Scanner, NMR, Spray View, TGA, UV-Vis, Particle Size Analyzer (Microtrac), Surface Area Analyzer (Horiba);
Must have BS or equiv. and 10 years prior exp. in similar duties.
Mail resumes, cover letter, salary history, to MGM Integrated Solutions, LLC, 420 Lexington Avenue, Suite 300, NY, NY 10170, Attn: HR MGR w/Ref: 0316.