Evan Chen
Halifax,NS
Summary
4 years of Quality System Management experience with expertise on audits and inspections. Pharmaceutical GMP certificates with ISO 9001 back ground.
Overview
5
5
years of professional experience
Work History
Quality Systems Manager
Grifols
Halifax, Nova Scotia
09.2022 - Current
- Collaborated with production and operation teams and helped in opening a new plasma donation center in Halifax.
- Provided guidance on GMP regulations and ISO 9001, 2015 standards.
- Developed, implemented and maintained Quality System procedures to ensure compliance with regulatory requirements.
- Provided training for staff in quality assurance practices, techniques and principles.
- Reviewed and maintained records of quality system documents, including SOPs, quality event reports, and calibration records.
- Prepared technical documents such as specifications, test protocols and validation plans.
- Created standard periodic performance metrics, outlining KPIs and areas of improvement for each department.
- Conducted internal audits to evaluate the conformance of processes and systems with Health Canada Blood Regulations standards.
- Assisted in preparation for external audits by regulatory agencies (Health Canada, GHA, and IQPP), and customers.
Quality Systems Manager
Canadian Plasma Resources
Moncton, New Brunswick
02.2020 - 09.2022
- Acted as lead supervisor in ensuring the day-to-day center activities of quality operations are compliant with SOPs and applicable federal and local regulations, as well as Human Resources policies.
- Managed creation, review/revision, and implementation of all documentation related to the local Quality Department, including SOPs, reports, records, test results, and equipment records and manuals.
- Conducted internal audits in designated Plasma Centers and helped design effective action plans.
- Assisted with external audits (Health Canada, Grifols) and the preparation of audit reports, elaboration of non-conformance reports, and response.
Education
Bachelor of Science - Biochemistry & Molecular Biology And Chemistry
Dalhousie University
Halifax, NS01-2020
Skills
- Quality Management Systems
- Document Management
- SOP Development
- Audits and Inspections
- Corrective and Preventative Actions
- Equipment Validation and Calibration
Timeline
Quality Systems Manager
Grifols
09.2022 - Current
Quality Systems Manager
Canadian Plasma Resources
02.2020 - 09.2022
Bachelor of Science - Biochemistry & Molecular Biology And Chemistry
Dalhousie University
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