Pharmaceutical Quality Assurance Consultant with Worldwide Experience

Technical Consultant #1057


Expertise

  • Forty years of pharmaceutical and biotech industry experience - Production and development environments.
  • Validation (computerized systems, equipment, processes), pre-acquisition - due diligence, quality assurance, compliance, quality control, research and development, technology transfer and clinical operations.
  • Small and large molecule and vaccines, (Flu, Anthrax, and Rabies).
  • International and domestic experience and assignments, (Europe, China and India).
  • Exit strategy development, tracking and adjustment.
  • Working with small, medium and large firms, assisting and managing; start-ups, start-overs and providing individual consulting services, of well established organizations.

Sterile Products

  • Noted clients served: DuPont Pharmaceuticals, Ohmeda Pharmaceuticals, Searle Pharmaceuticals and Aventis Behring.
  • Marketed product, research and development, pilot plant operations, (product formulation) and technology transfer.
  • Liquids, emulsions and lyophilized products.
  • Aseptically filled, terminally sterilized, formulations with preservative systems.
  • Buffered and non-buffered formulations.
  • Ampules, multi dose vials, single dose syringes (i.e. Hypak System).
  • Two container purge/fill/purge (i.e. Cozzoli) and high speed lines (i.e. Strunck and Calumatic).
  • Manual light inspection and automated equipment (i.e. Esai).
  • Manual and high speed labeling.
  • Manual and automated packaging lines.
  • Sterile facility (and supporting micro lab) design, construction, start up, validation and operation.
  • Equipment selection, FAT, Installation, start up, validation.
  • SOP, work instruction and batch record development, implementation and training.

Consulting

  • Automated systems (general): Selection, implementation, validation, training and go-live assistance.
  • Enterprise Resource and Planning (ERP - SAP) and SAS (Clinical Data Management) - System implementation, validation, training and utilization: Guided clients during the planning, implementation and go-live transition phases to assure that planning, logistics, data migration and quality management were enhanced.
  • Quality / quality systems and compliance: Evaluation, enhancement and remediation.

Experience

Undisclosed Company, Founder, 2004 - Present

  • Quality and compliance consulting.
  • Consent decree auditing and remediation.
  • SAP Implementation - Quality and compliance oversight.
  • Sterile and solid dosage form manufacturing subject matter expert.
  • Project team management: RFP development, proposal evaluation, partner and personnel selection, scheduling, cost estimates and containment, status reporting and presenting, deliverable assurance, SOP's and training - making it all happen.
  • Compliance auditing: Conducting, reporting, evaluation for regulatory exposure potential, remediation planning and execution project management
  • Quality systems: Evaluation of status, enhancement suggestions, planning and execution.
  • Management substitution: Short and long term.
  • AIP (Application Integrity Policy): Comprehensive data review to assure the integrity of data presented to the FDA, this included:
  • Clinical data review.
  • Evaluation of data management procedures and processes.
  • Analytical data.
  • Validation - methods, processes computerized systems.
  • All records.

Clarkston Consulting, International Consultant and Project Management, 2002 - 2004

  • SAP implementation with vaccines manufacturer - focus on quality management (in United States and United Kingdom).
  • Focus on Clients who manufacture sterile products.
  • Facilitated a very effective SAP implementation.
  • Bridging the understanding gaps among SAP / automated system implementation consultants and client quality management, successful alignment of these groups.

KMI/Parexel Consulting, Senior Consultant, 2002

  • Quality systems evaluation and implementation.
  • Focus on clients who manufacture sterile products.
  • Facilitated useful quality system evaluations from which effective remediation plans were developed.
  • Capability to quickly understand company culture from quality management and business perspectives and then draw the client in to remediation planning that is intuitive to the majority/key players.

Aventis Behring, Marburg, Germany - Sr. Director, Quality Assurance and Compliance, 2001

  • Remediation planning and preparation for FDA and EU regulatory agency inspections.
  • FDA inspection host; successful in shaping employees thinking relative to perception of what the FDA is looking for during as inspection of a foreign manufacturer and risk assessment in alignment with the ethics of the pharmaceutical industry.

Duramed Pharmaceuticals, Cincinnati, OH, Vice President Quality Operations, 2001

  • Generics and NDA.
  • Staff of one hundred twenty QA, QC and compliance professionals.
  • Managed preparation for and successful FDA, German MOH and DEA inspections.
  • FDA Inspection Host.
  • Guided management towards balance decision making with regards to potential product recalls.
  • Articulating the facts in an objective and structured manner thereby facilitating appropriate decisions, actions and management of opinions.

Searle Pharmaceuticals, (Monsanto), Chicago, IL, Director, International Quality Assurance, 1997 - 2000

  • Provided client with manufacturing expertise and FDA experience.
  • Quality operations for strategic and regional operations in Europe.
  • International support in: Germany, Italy, United Kingdom and Moscow and Russia.
  • Managed preparation for successful FDA and other EU regulatory agency inspections.
  • FDA Inspection Host.
  • Implemented corporate quality systems into European pharmaceutical operations.
  • Successful FDA inspections of sites that had minimal or no experience in managing foreign (U.S.) inspections.
  • Effective organizational and teaching skills.

Ohmeda Pharmaceuticals, Liberty Corner, NJ, Associate Director Validation, 1991 - 1997

  • Sterile manufacturing, (emulsions), API and biotech manufacturing process validation in Puerto Rico, the U.K, and other European locations.
  • Subject matter expert during FDA and MCA inspections.
  • Key input and presentation during PAI and pre PAI relations, complete with perseverance and good communication skills.

Fluor Daniel, Marlton, NJ - Validation Department Manager, 1990 - 1991

  • Department initiation and development.

Eastman Pharmaceuticals and Sterling Drug, Great Valley, PA, 1988 - 1990

  • Manager of Quality Assurance and Research and Development.
  • Small molecule and biotech research operations including, Laboratory operations in the U.S. and the U.K.
  • Clinical site selection, auditing and routine monitoring, working at numerous two sites: MD Anderson in Houston, TX and Royal Victoria Institute in the U.K.
  • Motivated non-GMP lab operations to become acceptable to perform marketed product release testing.

Dupont Pharmaceuticals, (Endo Laboratories), Manager, 1972 - 1988

  • Working in several locations: Garden City, NY, Wilmington, DE and Manati, Porto Rico.
  • Manager sterile manufacturing operations and manager sterile pilot plant operations.
  • Marketed sterile products manufacturing, sterile formulation development, technology transfer and formulation trouble-shooting.
  • Solid dosage formulation.
  • Packaging line supervisor.
  • Quality assurance Supervisor.
  • Key player during transfer of line of sterile products to new facility in Manati, PR.

Other Professional Activities

  • U.S. Army

Education

  • B.S. Biology from Neumann College in Aston, PA
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