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Pharmaceutical Consultant: Analytical Methods Validation, Computer Systems Validation and QA/QC

Technical Consultant #1026


Expertise

  • Analytical Techniques: GC, HPLC, GC/LC/MS, FTIR, UV-Vis.
  • Stability-indicating method development, validation and transfer.
  • Analytical equipment validation: IQ, OQ, PQ.
  • Part 11 compliance and GAP analysis.
  • Validation master plan development.
  • Stability protocol development.
  • CTD dossier preparation.
  • Cleaning validation strategy.
  • LIMS and Laboratory Data Acquisition Computer systems.
  • Coumadin, Percodan, Naloxone, Numorphan and Naltrexone .
  • Software Applications: Documentum, Trackwise, ISOtrain, ERP/MRP, EDMS, Maximo.
  • Computerized systems validation deliverables: UFRS, CRS, FAT, SAT, IQ/OQ/PQ, RTM, VSR.
  • Preparing compliance documents, SOP's, validation and CMC stability summary reports.

Experience

Independent Consultant, New York, 2002 - Present

  • Created Module 3 CTD Dossiers for registering OTC products in new overseas markets.
  • Prepared CTD GAP analysis for needed materials for drug substances and excipients.
  • Provided QA/QC for clinical documentation by revising and editing PK/PD reports CTD module 5 and 2 clinical sections for an NDA registration package.
  • Audited LC/MS method validations in support of clinical trials testing and documenting risk assessments in response to FDA warning letters.
  • Prepared, executed and conducted reviews of CSV deliverables including compliance assessments, corrective action plans, CSV and SLC documentation, test scripts, test summary logs, and validation summary reports for computer system validation.
  • Conducted audits for GMP operational compliance and development of responses to FDA compliance problems, notices of observations, warning letters and consent decrees.
  • Subject matter expert on computer system validation for Part 11 issues.

Emisphere Technologies, Inc., Tarrytown, NY Associate Director, Quality Support Services 2000 - 2002

  • Managed operations of a quality control unit including the GMP laboratory documentation control and stability.
  • Designed new analytical testing laboratories in conjunction with facilities expansion.
  • Prepared commissioning and validation documentation for major laboratory equipment upgrade.
  • Approved all IQ/OQ/PQ validation protocols and executed protocols for CGMP compliance.
  • Authored compliance documents, stability reports for CMC sections, SOP's specification documents and certificate of analysis ( COA's ), stability portions of the CMC section for NDA filings.
  • Prepared out of specification (OOS ) investigation reports, GLP toxicology sample analysis summary reports, and reporting of clinical pharmacokinetic data.
  • Completed computer validation report for laboratory Turbochrom workstation.

G&W Laboratories, Inc., R&D Manager, South Plainfield, NJ, 1997 - 2000

  • Managed operations of an R&D lab with for new semi-solid OTC product development.
  • Prepared cleaning validation master plan for all products to adequately address warning letter deficiencies which resulted in product withdrawals.
  • Prepared 13 product cleaning validation protocols and authored all reports within 6 months without any FDA 483 observations upon re-inspection.
  • Investigated vendors and coordinated demonstrations of new laboratory chromatography data systems to comply with up-coming 21 CFR Part 11 requirements.

Clay-Park Labs, Inc., Laboratory Manager, Bronx, NY, 1995 - 1997

  • Managed new semi-solid product development with contract manufacturing and research firms to ensure compliance with QC criteria, SOPs, GMPs and contractual guidelines.
  • Directed the successful and on-time start-up and operation of a new R&D lab for semi-solid generic, OTC and cosmetic new product development.
  • Wrote 25 SOPs and trained staff to rectify all laboratory FDA 483 compliance observations.
  • Conducted training on CGMPs and new revised SOPs.
  • Authored, published and validated HPLC methods for Nitrofurazone products in USP PF.

Other Positions

  • DuPont Merck Pharmaceutical Co., Technical Support, Garden City, NY, 1990 - 1994
  • Pall Corporation, Laboratory Manager, Glen Cove, NY, 1989 - 1990
  • Pepsico, Inc., Senior Chemist, Valhalla, NY, 1987 - 1989
  • Lederle Labs, Development Chemist, Pearl River, NY, 1986 - 1987
  • Revlon Health Care, Senior Chemist, Tuckahoe, NY, 1981 - 1986
  • Chemtech Consulting Group, Inc., Group Leader, New York, NY, 1980 - 1981
  • Equitable Environmental Health, Inc., Analytical Chemist, Woodbury, NY, 1979 - 1980

Education

Ph.D., Organic Chemistry, Polytechnic University, Brooklyn, NY

M.S. Geochemistry, Rensselaer Polytechnic Institute, Troy, NY

B.S., M.A., Chemistry, Queens College, Flushing, NY

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