Contact Information

T: (905) 363-1182
F: (905) 542-7981

TF: 1 (877) 877-5152
E: rtaddese@qualityandcompliance.com

2550 Argentia Rd., Suite 119, Mississauga ON L5N 5R1
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Associate Consultant

Redi Taddese is a highly reliable individual with background in qualification (IQ/OQ/PQ) protocols, Good Documentation Practices (GDP), and Good Manufacturing Practices (GMP). She works effectively under pressure and functions well as both a team player or as an individual. Her analytical skills, work experience, and educational background add to the depth of the QCR team.

Skills and Highlights

Quality Assurance

  • Provided quality assurance support in preparation of a Health Canada inspection.
  • Prepared equipment-related work instruction, production procedures, master batch records and quality assurance SOPs.
  • Coordinated a departmental compliance improvement initiative. Update SOPs, author study protocols and reports, and manage personnel involved in the project to ensure timely completion.
  • Performed gap assessment on laboratory softwares and updated software work instructions to ensure 21 CFR part 11 compliance.
  • Assisted laboratory manager or designate during OOS and deviation investigations.
  • Scribed for Health Canada and FDA pre-approval inspection audits.
  • Revised QC sampling schedules, Certificates of Analysis, QC test result summary reports through change controls.

Validation

  • Prepared and reviewed IQ/OQ/PQ protocols and reports for QC instrument qualifications.
  • Reviewed test method validation protocols and reports.
  • Participated in test method feasibility, method transfer, qualification and validation studies.

Quality Control

  • Exercised good documentation practice (GDP) to generate raw data and reports.
  • Prepared client or compendia test methods used for in-process and release testing of QC samples.
  • Performed quality control review of test result documentations to ensure compliance with regulatory guidelines, approved protocols and procedures.

Awards, Recognition and Achievements

  • Chancellor’s Scholarship, University of Toronto.

Education

  • Project Management, University of Toronto.
  • Master of Science, Biochemistry, Univesity of Toronto, Toronto, ON.
  • Bachelor of Science, Honours, Biochemistry and Pharmacology, University of Toronto, Toronto, ON.