Genesis B Paredes Hernandez
Toronto
Summary
Accomplished professional with expertise in GMP guidelines and risk assessment. Spearheaded the implementation of a Contamination Control Strategy and developed an automated data trending system, enhancing operational efficiency. Demonstrated strong decision-making and communication skills while leading investigations and ensuring compliance with industry standards.
Overview
3
3
years of professional experience
Work History
QC Associate I, Microbiology
CCRM
01.2022 - Current
- Maintained expertise in GMP guidelines, including but not limited to Health Canada, PDA Technical Report No. 13 and EU GMP Annex I. Used knowledge to develop a risk-based decision-making process map to tackle viable recoveries in graded and supporting non-graded areas.
- As subject matter expert provided guidance in the areas of microbiology, aseptic processing, Contamination Control program and mitigation planning. Participated in the implementation of the company's first Contamination Control Strategy document.
- Maintained documentation of viable recoveries and total particulate monitoring; studied data trending for the facility at regular intervals. Participated in major revisions of trending reports and put into effect an automated system for a more accurate and consistent data trending.
- Designed, organized and maintained the Standard Operating Procedures (SOPs) that describe the company's equipment's’ key functions including, but not limited to, the operations and maintenance procedures. Lead the revision, training and initial deployment of new equipment SOPs.
- Oversaw the Environmental Monitoring (EM) program to support operations. Lead major revisions to the EM program and implemented a user-friendly, spreadsheet-based tracker of team activities to reduce the risk of procedural gaps.
- Lead the monitoring of deviations and Out Of Specification (OOS) incidents for the manufacturing facilities and conducted interdepartmental conversations for a timely resolution of these events. Handled Ishikawa root-cause analyses for major investigations.
Education
Advanced Diploma - Biotechnology
Seneca College of Applied Arts And Technology
North York, ON05-2022
Skills
Guideline reading and understanding
Continuous Improvement
Risk Assessment
Statistics
Decision-making
Organization
Communication (Verbal & Written)
Timeline
QC Associate I, Microbiology
CCRM
01.2022 - Current
Advanced Diploma - Biotechnology
Seneca College of Applied Arts And Technology
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