Microsoft Word - SPDS_0918_ERP-Proposal-07-11-2018DMC

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Elite Pharmaceuticals, Inc.

Northvale, NJ

Head of Quality Assurance and Compliance/Regulatory Affairs • Directed and managed all quality assurance functions at Elite to ensure company maintains full compliance with the FDA, DEA and all other applicable government agencies • Coordinated and prepared regulatory submissions (IND/NDA/ANDA/CBE30/PAS) • Led FDA, DEA and other client inspections and act as a company’s primary contact to regulatory authorities (FDA/DEA) and prepared responses to 483s, deficiency letters • Reviewed and approved all technical documentation such as equipment qualification, process validation, cleaning validation, analytical method validation, change controls, SOPs, and other study reports. • Led GMP Investigation and Resolution of OOS and OOT results • Tracked metrics and trends on compliance issues, training and resolutions • Administered and maintained the Quality Management Systems • Directed and coordinated supplier and internal audits and annual product reviews • Managed company’s documentation system, databases and logs • Coordinated and prepared customer complaints investigations and responses • Prepared, reviewed and approved all company SOPs Merck Summit, NJ Consultant for Pharm Stability QA Operation Nov 2009 to July 2010 • Conducted/reviewed stability assessments for global market and work with the cross-functional team to highlight gaps and make recommendations. • Proposed stability strategy for registration Elite Pharmaceuticals, Inc. Northvale, NJ Director of Analytics and QC 2006 to 2009 • Directed R&D and QC staff in daily operations to include: release and stability testing, in-process testing, analytics and QC inspections and audits, analytics and QC documentation, equipment maintenance and calibration and analytics and QC laboratory design and maintenance. • Responsible for Analytical method development and validation • Formulated and implemented new documentation practices, training programs, new analytics and quality control (QC) policies and weekly group meetings to boost group’s morale and efficiency. • Decreased the turnaround time for analysis by more than 50% to meet the company’s needs. • Drafted, finalized and implemented Company Policy to address attendance, vacation and sick leave in addition to travel expense policy. • Managed all human resources issues including disciplinary actions and benefits issues for the company. Purdue Pharma L.P. Ardsley, NY Assistant Director 2004 – 2006 • Provided analytical support for solid dosage forms in extended and immediate release formulations, suspensions, injectables and patches to product development teams • Led the efforts to improve standard operating procedures and regulation compliance Section Leader 2002-2004 • Directed and coordinated method development, method validation and characterization studies of test articles and dose preparation in support of nonclinical laboratory studies • Implemented, drafted and established procedures and SOPs to comply with GLP regulations • Drafted protocols, equipment procedures, validation and characterization reports July 2010 to October 2014