Contact Information

T: 905.363.1182 x.240
F: 905.542.7981

TF: 1.877.877.5152 x.240
M: 416.543.0046

2550 Argentia Road • Suite 119 • Mississauga ON • L5N 5R1
Download Printable CV

Senior Consultant

Alana is a dedicated and flexible Quality Assurance professional who leverages strong interpersonal skills and teamwork to achieve business objectives. With over 25 years of experience in quality assurance for Good Manufacturing Practices (GMP) and ISO systems, Alana consistently demonstrates excellent leadership, analytical, and communication skills. Her personal expertise and knowledge make Alana a valuable addition to any team.

Skills and Highlights

Quality Assurance/ Quality Control Officer (QCO)

  • Made disposition decisions on natural health products and pharmaceuticals, including vaccine products
  • Reviewed annual product quality reviews and stability documentation to ensure compliance with Health Canada requirements
  • Tracked and trended product quality compliants
  • Reviewed master manufacturing and packaging documentation
  • Reviewed and approved executed manufacturing and packaging documents for pharmaceutical and vaccine products
  • Prepared vaccine lot release protocols for submission to regulatory agencies
  • Responded to GMP questions from production
  • Prepared Quality Metrics presentations using data from SAP queries
  • Mentored staff on corporate quality management systems
  • Created an innovative listing of drug products and associated activities for use as a compliance reference document
  • Initiated, determined actions and closed actions for change controls related to all aspects of Quality Assurance

Deviations

  • Investigated deviation events originating in manufacturing areas and quality control laboratory (out-of-trend and out-of-specification results)
  • Determined root cause and corrective/preventative actions
  • Approved deviation and non-conformance reports
  • Worked with an inter-departmental team to close and improve the quality compliance of deviation reports

Technical Writing

  • Wrote quality systems Standard Operating Procedures (SOPs)
  • Created a periodic product review report template for imported and purchased products to comply with the requirements of the Canadian GMPs
  • Participated in the development of an Out-of-Specification SOP based on the ruling in the Barr Laboratories court case

Regulatory

  • Developed a process for the implementation and maintenance of a Drug Establishment Licence to ensure compliance with Health Canada requirements
  • Performed comparisons of master manufacturing and analytical testing documents against registered regulatory requirements

Auditing

  • Performed quality inspections of warehouse facilities
  • Performed assessments of quality systems SOPs against GMP regulations and current agency expectations
  • Scheduled and performed internal Quality Systems audits
  • Implemented a risk-based site inspection program that ensured that production and support areas and processes were compliant with GMPs while maintaining focus on core business objectives
  • Aided production and support areas in the implementation of their departmental/self inspections
  • Prepared responses to Health Canada audit observations
  • Played an integral role in the support teams of successful Health Authority pre-approval and GMP inspections

GMP Training

  • Developed and presented training modules on Canadian, American and European GMP, and Canadian Medical Device requirements

Laboratory

  • Demonstrated flexibility and adaptability by leading various Quality Control laboratory teams through the processes of sampling, packaging component, and raw material and drug product testing
  • Ensured raw materials and products were tested, reviewed, and released in order to effectively and efficiently meet business needs in a manner consistent with regulatory and GMP standards
  • Improved the format and content of product specifications, reducing the amount of repeat testing and improving laboratory output

Computer Skills

  • Document Management Systems
  • LIMS
  • NuGenesis
  • SAP
  • TrackWise
  • Visio

Education

  • Chemical Technology Diploma, Honours, Humber College of Applied Arts and Technology, Etobicoke, Ontario

Continuing Education

  • Auditor Certification (corporate program)
  • Basic Solid Dose Technology (Level 1)
  • Computer System Inspection Readiness Workshop
  • Computer System Validation
  • Current GMP Training
  • Drug Product Stability & Shelf-Life
  • Effective Quality Assurance Auditing for cGMP Compliance
  • Good Laboratory Practices
  • Good Manufacturing Practices - Concepts and Implementations
  • Good Manufacturing Practices - Getting More Productivity
  • International Good Manufacturing Practices Conference (FDA, Industry)
  • ISO Overview and Auditing
  • ISO 13485:2003 - Essentials Course
  • Lean Sigma Advocate
  • Liquid Dose Technology (Level 1)
  • Medical Devices Regulatory Requirements & the Inspection Program
  • Pre-Approval & GMP Inspections - A Global Perspective
  • Regulatory Inspection Program for Medical Devices
  • Technical Writing
  • Understanding the Science of Vaccines
  • Update on Quality Challenges Facing the Pharmaceutical Industry (FDA, Health Canada, USP)
  • Validation Guidelines for the Pharmaceutical Industry
  • Workplace Health & Safety