Contact Information

T: 905.363.1182 x.245
F: 905.542.7981

TF: 1.877.877.5152 x.245
M: 416.567.6967

2550 Argentia Road • Suite 119 • Mississauga ON • L5N 5R1
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Senior Consultant

Anna is a team-oriented Analytical Scientist with extensive experience in a laboratory setting with a focus on pharmaceutical product development and product quality. She is well-versed in technologies used to develop control strategies for analytical development. She has performed global implementation of scientific methods and Standard Operating Procedures (SOPs) in compliance with the needs of the world's major regulated environments. Anna is recognized as a leader in planning, organizing, executing, and troubleshooting laboratory experiments in response to project needs while maintaining a strong emphasis on Quality. Over the years, Anna has built and fostered strong relationships that have provided the tools necessary to work in a collaborative environment.

Anna's knowledge of Good Manufacturing Practices (GMPs), Good Laboratory Practices (GLPs), ICH, and FDA regulations, as well as her project management, mentoring, and negotiation skills, and proven communication skills across various levels of the organization, are an asset to both Q&C and our clients.

Skills and Highlights

Quality Assurance

  • On-Site Consulting – Project Management
  • Investigated, wrote, reviewed, and approved deviations
  • Reviewed and approved unexecuted batch production records for filling, examining, labelling, and packaging orders
  • Reviewed and approved executed batch production records
  • Reviewed and approved autoclave sterilization records
  • Performed AQL (Acceptable Quality Limit) visual inspection of finished product and is recognized as an expert in product AQL inspection
  • Served as Designated Trainer for Batch record review, Batch record Issuance, AQL Visual Examination, and Deviation reporting
  • Analyzed raw materials, bulk, in-process, and finished products to ensure compliance with regulatory and corporate specifications
  • Operated HPLC, GC, IR, and UV-VIS instrumentation; dissolution apparatus (USP Apparatus I and II); Karl Fischer moisture titration
  • Used routine wet chemical analyses techniques (Loss on Drying, Residue on Ignition, titration, etc.)
  • Performed analytical testing of bulk, raw materials, and finished product in a manufacturing environment. Timely communication of results to production and plant supervisors to facilitate necessary changes/optimization to production parameters
  • Graded raw materials

Laboratory

  • Developed a customer-focused approach to sample preparation for an impurities assay that resulted in a more streamlined method. The final sample preparation technique was in line with the needs of the Global Quality Control lab that would be responsible for executing the method once the drug product was commercialized
  • Developed and implemented a control strategy for water activity which proved to be a better indicator of chemical degradation of the drug product. This new strategy eliminated the need for costly microbial testing of the drug product
  • Developed and implemented a control strategy for dose confirmation testing in our off-site laboratory. This streamlined approach greatly reduced the amount of training and documentation required for the lab to conduct the testing, which enabled the off-site lab to quickly use the new methodology to release product into their marketplace
  • Investigated unknown impurities in solid oral dosage forms and communicated results of the investigations to other labs running the method such that the appropriate strategy could be used in the quantitation of the unknowns
  • Developed, validated, and transferred analytical methods within agreed-upon timelines resulting in the timely startup of Registration Stability studies. Methods were successfully transferred to global affiliates
  • Planned experiments and generated data in support of formulation development efforts. Data was scientifically assessed and conclusions drawn were communicated back to formulation scientists so that next steps in formulation design could be evaluated
  • Overcame analytical obstacles during method transfers, which resulted in smooth startup-to-registration stability studies
  • Organized information on analytical development for a drug product and made a presentation to senior management on the manufacturability of a drug product in relation to analytical capabilities which contributed to the positive decision on the readiness of the technology transfer to the manufacturing site
  • Coordinated and tested samples for photo stability and stress test screens in accordance with ICH guidance. Evaluated and summarized data. Technically presented on the topic of stress testing results and published an internal technical report which was included in the submission for the drug product
  • Six Sigma Process Improvements: Member of a Six Sigma Team that transformed the method for exporting samples to the US resulting in a compliant and consistent process
  • Generated and evaluated data for stability studies in support of global product submissions for a variety of drug compounds

Regulatory

  • Contributed to Regulatory Submissions
  • Provided written responses to queries from Regulatory Bodies

Auditing

  • Performed GMP Audits for Active Pharmaceutical Ingredient (API)/manufacturing facilities
  • Experienced with FDA and Ministry of Labour Inspections
  • Experienced with Site Self- Inspections
  • Leadership role in Corporate Health and Safety Audits
  • Coordinated Joint Health and Safety Committee (JHSC) inspections for a site. Ensured that all findings were addressed in a timely manner. Investigated trends in findings and proposed corrective actions

Technical Writing

  • Developed content, authored and reviewed SOPs
  • Researched and authored technical reports

Computer Skills

  • Scientific/Informatics: Admin/Lims, ILIMS, Trackwise, GMP/GLP Analytical Testing, SAP, HPLC, Impurities Analysis, GC, FTIR, and Dissolution
  • Regulus, Documentum and eDoc

Awards, Recognition and Achievements

  • Achievement Award (Eli Lilly 2003)
  • Quality Advocate Award (Eli Lilly 2002)

Publications

  • Publication: Contributor to Chapter on Dissolution Method Development and Validation in a textbook: Analytical Method Validation and Instrument Performance Verification. Chung Chow Chan (Editor), Herman Lam (Editor), Y.C. Lee (Editor), Xue-Ming Zhang (Editor)
  • Publication: Comparison of the Effectiveness of Various Deaeration Techniques:  Owen S. Degenhardt 1, Bonnie Waters 1, Anna Rebelo-Cameirao 1, Annelene Meyer 2, Heiko Brunner 2, and Nicholas P. Toltl 1

Education

  • Bachelor of Science Degree, Ryerson University, Toronto, Ontario
  • Conducted thesis research on how one could extend the shelf life of shredded lettuce and cooked potatoes by modifying the component gases in the packaging

Continuing Educaiton, Career Development

  • Advanced Dissolution Method Development and Validation
  • Advanced HPLC Method Development
  • Analytical Method Validation
  • Chemical Emergency Response Training Investigation & Documentation of Suspect Analytical Results
  • Fundamentals of Dissolution Testing
  • Industrial Drug Legislation
  • Internal Auditor Trainer for FDA Regulated Industries (SAI Global)
  • JHSC Certification Parts I and II
  • Standard First Aid/CPR AED Level A
  • Train-the-Trainer
  • Workplace Health & Safety