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
- 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.
- 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.
- 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.
- 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.