Contact Information

T: 905.363.1182 x.237
F: 905.542.7981

TF: 1.877.877.5152 x.237
M: 647.330.3977

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

Kai is an experienced quality assurance professional with more than 10 years in the pharmaceutical industry. She is a skilled auditor with a strong understanding of the GMP/GLP (Good Laboratory/Manufacturing Practices) regulations and Quality Systems, as well as, excellent audit report writing, tracking and follow-up skills. When you combine these with her attention to detail, tactfulness, self-motivation and strong work ethic, it is clear how Kai is a valued asset to both Q&C and our clients.

Skills & Highlights

Quality Control / Assurance

  • Performed timely document review (laboratory notebook, Standard Operating Procedures [SOPs], documents related to method validation/verification, stability studies, non-conformance and Out of Specification [OOS] investigation reports) to ensure accuracy, completeness and compliance with GLP/GMP, all applicable SOPs, and regulatory requirements
  • Issued and approved certificates of analysis
  • Developed customer complaint system, conducted and followed up on customer complaint investigations with various departments, and responded to customer complaints
  • Followed up to ensure completion of corrective and preventative actions resulting from the investigations of complaints, non-conformances, and OOSs
  • Performed annual trending for non-conformances and customer complaints
  • Reviewed APQRs, Master Packaging and Master Manufacturing documents for fabricators
  • Reviewed SOPs and Study Plans/Protocols for GLP elements
  • Monitored equipment calibration and maintenance
  • Monitored SOP and Study Plan deviations
  • Prepared and signed Quality Assurance statements in final audit reports
  • On-site consulting project management

Auditing

  • Performed annual GMP audit, as well as other audits for various departments ensuring operations are carried out according to approved procedures and in accordance with GMP/current GMP (cGMP) requirements
  • Generated audit reports
  • Participated in various audits: US FDA, Health Canada, Standards Council of Canada (SCC), National Environmental Laboratory Accreditation Conference (NELAC), and customer audits
  • Performed regular GLP facility inspections, reported audit findings, and followed up on corrective actions
  • Performed in-phase audits of all phases of the GLP studies for pesticides (sample log-in, extraction, analysis, raw data, and final analytical phase report)
  • Performed logbook audits and identified gaps which were addressed through non-conformances and CCRs; streamlined auditing process to ensure timely review

Regulatory

  • Responsible for import drug registration
  • Responsible for license applications, license renewals, and all quality regulatory submissions
  • Worked closely with Quality Assurance Department and Marketing Department to prepare and review labeling, marketing, and training materials
  • Assisted Regulatory Affairs Manager in resolving regulatory compliance issues
  • Maintained registration documentation to ensure compliance and fast tracking

Pharmacology

  • Secured government funds for new research project
  • Planned and organized research projects, including establishing appropriate animal models, developing analytical methods, and training laboratory research staff
  • Performed routine toxicological, pharmacodynamics, and pharmacokinetic experiments
  • Compiled testing data and wrote reports

Training

  • Performed WHMIS training

Education

  • Master of Science, Biochemistry and Molecular Biology, School of Life Science, Zhejiang University, Hangzhou, China
  • Bachelor of Science, Pharmacology, School of Pharmacy, FuDan University (formerly Shanghai Medical University), Shanghai, China

Continuing Education, Career Development

  • Pharmaceutical Quality Control Diploma Program
  • Validation, Verification and Transfer of Analytical Methods
  • ISO17025: 2005 internal audit course
  • Conducting Effective Auditing of GMP Documentation Workshop
  • Sharepoint