Contact Information

T:(905) 363-1182 x 247
F: (905) 542-798

TF: 1 (877) 877-5152 x 247

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

Flora Suen is a capable quality assurance professional, with 8 years of experience in the pharmaceutical and biologics industries. Flora has experience with deviations and root cause analysis, and corrective and preventative action (CAPA) plans and Change Controls. Flora has excellent interpersonal skills, and strong organizational and time management skills. Flora’s analytical skills, work experience and educational background add to the depth of the QCR team.

Skills & Highlights

Quality Assurance

  • Managed site documentation through the electronic document management system (Documentum).
  • Managed central records management process.
  • Managed approval of master batch records, and issuance of batch records on site.
  • Assess product, compliance and operational risks to develop risk management strategies.
  • Coordinate external audits/inspections.
  • Standardized continuous improvement initiatives across seven (7) QC departments.
  • Improvement of OOS/OOT Procedure Process flow in alignment with FDA guidelines and global quality documents.
  • Managed major, critical, recurring non-conformances, develop risk assessments and CAPA.
  • Perform tracking and trending of non-conformance metrics associated with Quality Control using LEAN methodologies.
  • Performed deviation investigations.
  • Implemented Technical Writing eLearning, and created a compliance training module for a site.
  • Performed in-process, finished product, and stability testing.

Validation

  • Prepared a validation master plan for the microbiology lab

Regulatory

  • Reviewed cGMPs and industry guidance documents and implement changes when gaps are identified using major quality systems (CCR, CAPA, Electronic Document Management System).
  • Coached staff in problem solving and provide guidance during investigations.

Technical Writing

  • Revised SOPs in alignment with compendial methods, compiled annual product reviews (APRs), trend reports, wrote and executed validation protocols.
  • Drafted new procedures for new document system implementation.

Education

  • Master of Science – Biology, McMaster University, Hamilton, ON
  • Bachelor of Science – Biology (Molecular Biology and Biotechnology Specialization), University of Waterloo, Waterloo, ON