Contact Information

T: 905.363.1182 x.236
F: 905.542.7981

TF: 1.877.877.5152 x.236

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

Kimberley Eastman has over 10 years of experience in the Pharmaceutical industry, areas of focus include quality assurance and quality control.  She is proficient in, performing/hosting audits, supporting self-inspection programs, developing procedures, executing non-conformance investigations, addressing complaints, and implementing CAPAs for gaps or deficiencies.

Skills and Highlights, Big projects

Quality Assurance

  • Audited and Reviewed batch records for drug (DIN)
  • Released drug products to the Canadian and US markets
  • Prepared quality system reports for results tracking to evaluate gaps and improvement initiatives
  • Developed and revised Standard Operating Procedures (SOPs) to ensure ongoing compliance with Health Canada regulations
  • Participated in the training of staff with respect to audit readiness activities
  • Investigated and evaluated non-conformances to determine risk assessment, root causes, the effect on product quality, affected materials disposition, and corrective/preventive actions
  • Oversaw the handling of complaint investigations along with the implemention of the necessary CAPAs
  • Prepared Annual Product Quality Review (APQR)
  • Responsible for the development and issuance of tasks based on Health Authority Inspection Report findings to mitigate/prevent repeat observations
  • Participated in self-inspection program and maintained records of site actions taken
  • Developed a process for gap/feedback analysis by internal customers to drive continuous improvement with respect to Health Authority Inspection outcomes
  • Pioneer member of Quality improvement team which oversaw the introduction of quality intiatives that aimed to increase output and reduce downtime

Auditing

  • Acted in both host and support roles with respect to multiple Health Canada Drug Establishment License GMP inspections
  • Supported FDA inspections of Canadian manufacturing facilities
  • Hosted multiple supplier audits (GMP inspection)
  • Oversaw the tracking and follow up of activities related to the resolution of audit findings to ensure that all responses required were collected and submitted to the agency on time 
  • Performed GMP inspections of contract vendors (manufacturing, packaging, lab), API, excipient, packaging components (labels, containers)
  • Performed inspection of Canadian third party storage and distribution warehouses to GMP standards

Technical Writing

  • Experienced in report writing with respect to audit reports, annual product reviews, standard operating procedures and work instructions

Training

  • Delivered SAP Training -Quality Management Module
  • Delivered Audit Readiness Training to company personnel
  • Delivered Pre-shift talkers to staff on various quality issues

Computer Skills

  • SAP, Oracle, Trackwise, Documentum and SharePoint

Education

  • York University, Bachelor of Science (BSc.) Toronto ON.
  • Seneca College, Pharmaceutical Chemical Technology Diploma, Co-op stream, Honors.