Contact Information

T:(905) 363-1182 x 276
F: (905)542-7981

TF: 1 (877) 877-5152 x 276

2550 Argentia Rd • Suite 119 • Mississauga ON • L5N 5R1
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Lead Consultant

Ella Ye is an experienced quality assurance professional, with 20 years of R&D experience and 12 years of quality assurance experience in the pharmaceutical industry. Ella has extensive auditing experience, including experience performing laboratory audits, data system audits and manufacturing process audits. Ella has superb communication skills, with substantial technical training and formal education. Ella adds to the depth of the QCR team.

Skills & Highlights

Quality Assurance

  • Participated in strategic meetings to set up the scope of the quality policies and quality management system of a company. Drafted and improved the quality manual.
  • Detail-oriented document reviewer and QA inspector.
  • Reviewed and examined batch records and source data and closely monitored each step of manufacturing procedures.
  • Conducted process evaluation through quantitative analysis. Performed risk analysis and pressure tests to validate the robustness of the process.
  • Proposed and conducted preventive maintenance of instrument/equipment to reduce downtime and instrument failure.
  • Setup tracking logs to minimize the risk of failure and improve data quality, and generate reports to optimize production.
  • Conducted out of specification/out of trend (OOS/OOT) investigations, generated investigation reports and/or Corrective and Preventive actions (CAPA) reports as needed.
  • Participated in internal and external auditing. Conducted routine QA inspections and investigations to determine root-cause of non-conformances. Performed a forensic inspection of the company’s whole document system covering each stage of manufacture and lab analysis.
  • Worked out an efficient data screening model, and improved the efficiency of data screening.
  • Worked in a team to prepare for an FDA audit resulting in zero observations
  • Prepared reports and authenticated CofAs with C.Chem. credential.

Validation

  • Performed analytical methods development, optimization and validation.
  • Designed testing protocols, prepared samples, and conducted qualitative and quantitative testing for both hardware and software verification.
  • Executed IQ/OQ/PQ inspection for new instrumentation.
  • Performed QA verifications to test the effectiveness of software functions and features.

Quality Control (QCO)

  • Conducted analysis on raw material and finished products
  • Generated compliant documentation as per regulatory requirement in a timely manner.

Technical Writing

  • Drafted company’s quality manual and continuously updated and validated it.
  • Developed and continuously updated standard operation procedures (SOPs) and test scripts to improve the quality of services and operation.
  • Composed test protocols, methods, SOPs and WIs

Education

  • Industrial Pharmaceutical Technology Program (IPTP) certificate in QA and GMP, Seneca College, Toronto, ON
  • Master of Science (M.Sc.), Chemistry, University of Toronto, Toronto, ON
  • Bachelor of Science (B.Sc.), Chemistry, Peking University, Beijing, China