Contact Information

T: 905.363.1182 x.220
F: 905.542.7981

TF: 1.877.877.5152 x.220
M: 416.357.4606

2550 Argentia Road • Suite 119 • Mississauga ON • L5N 5R1
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Director, Technical Services

Steve Hennigar, P. Eng., brings strong analytical and communication skills to Quality & Compliance Services Inc. (Q&C®). His positive outlook and proven problem-solving abilities allow Steve to complete projects and tasks efficiently without compromising quality. Steve's presentation of his research thesis on the chemical modification of polymers was given a Neish award by Queen's University faculty and industry members.

Skills and Highlights

Validation

  • Reviewed protocols for compliance to Health Canada and FDA requirements
  • Initiated, investigated and determined corrective and preventative actions for deviations and non-conformances
  • Drafted heating, ventilation and air conditioning (HVAC) Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols
  • Drafted and executed equipment IQ/OQ protocols for pharmaceutical and medical device manufacturers and packagers
  • Performed Qualification (IQ/OQ) on warehouses, freezers and refrigerators, including temperature mapping of small size refrigerators and walk-in refrigerators
  • Drafted Process Master Validation plans
  • Drafted and executed analytical method validation protocols for drug product manufacturer
  • Developed protocol and performed process validation for large-scale chemical manufacturer
  • Drafted retrospective Process Validation protocols
  • Developed computer validation project plan for NHP manufacturing company
  • Evaluated computer systems for validation plan requirements
  • Performed validation on filling and packaging operations for drug manufacturing company
  • Initiated, determined actions and closed actions for change controls related to Validation
  • Performed shipping validation studies

Quality Assurance/Quality Control

  • Acted as Director of Quality for a large pharmaceutical company (approx. 400 employees), making day to day quality decisions, maintaining compliance and increasing production fill rates, over a 4 month period
  • Managed Quality department of a drug manufacturer, allowing them with Health Canada’s permission to continue operations under an NC rating; C rating was ultimately re-instated
  • Performed full range of on-site quality control activities for a manufacturer of drug, natural health products and medical devices
  • Initiated, determined actions and closed actions for change controls related to all aspects of Quality Assurance
  • Initiated, investigated and determined corrective and preventative actions for deviations and non-conformances
  • Supervised recall of Canadian drug products
  • Supervised 15 people in Quality Assurance department, the QC Chemistry Lab and maintenance
  • Worked with client to hire personnel for the QA group through interviews
  • Addressed Health Canada Audit observations to bring the client into compliance

On-site Consulting

  • Reviewed more than 2,000 batch production records to assist with biologic manufacturer's backlog due to staffing transitions
  • Produced medical devices according to FDA requirements in Good Manufacturing Procedures (GMP) environment

Auditing

  • Performed internal audits to ensure compliance with corporate quality standards
  • Hosted Health Canada inspections
  • Performed audits to ensure compliance to Health Canada Drug GMP regulations, Natural Health Product (NHP) GMP regulations, and FDA Current GMP (cGMP) regulations of manufacturers, packagers/labelers, importers and wholesalers
  • Coordinated and executed self-inspection program for pharmaceutical and NHP facilities

Technical Writing

  • Drafted and revised cleaning procedures and work instructions to meet GMP standards

Computer Skills

  • SharePoint (administrator)
  • BillQuick (administrator)
  • SAP
  • Visio

Publications

  • Worked on project resulting in publication of "Determination of Alkoxyamine Concentrations in Nitroxyl Mediated Polymerization Products." Macromolecules, 35, 7628-7633 (2002)
  • Worked on project resulting in publication of "Silica Agglomeration and Elastomer Reinforcement: Influence of Surface Modification." Plastics, Rubber and Composites, 32, 1-8 (2003)

Education

  • Bachelor of Science, Engineering Chemistry, Queen's University, Kingston, Ontario

CONTINUING EDUCATION, CAREER DEVELOPMENT

  • Shipping Validation
  • Analytical Method Validation
  • Design and Validation of Critical Utility Systems
  • Process & Cleaning Validation
  • Validation Master Plan - Roadmap to Compliance
  • Practical Method Development & Validation for HPLC (Waters)
  • cGMP Overview
  • Fundamentals of Dissolution
  • Fundamentals of GMP for Packaging Suppliers
  • GMP for Importers/Distributors
  • GMP Overview
  • GMP Training
  • Industrial Drug Legislation
  • Advanced GMP Auditing
  • Auditing Skills
  • ISO Internal Auditor
  • ISO Overview
  • Manufacturing Control in the Pharmaceutical Related Industries
  • Review of Analytical Data
  • SOP Writing
  • Technical Writing Course
  • WHMIS certification
  • Data Integrity