SARA BABAEIRAD
Laval,QC
Summary
Quality Assurance Specialist with over four years of experience in regulated manufacturing environments, specializing in Quality Management Systems (QMS), GMP compliance, document control, change management, deviation investigations, CAPA implementation, product release, supplier quality management, and continuous improvement. Proven experience developing SOPs, supporting Health Canada inspections and international audits, managing quality documentation, coordinating cross-functional teams, and ensuring regulatory compliance throughout manufacturing operations. Strong analytical, organizational, and technical writing skills with a passion for maintaining high-quality standards in highly regulated industries.
Overview
12
12
years of professional experience
Work History
Quality & Process Engineer
Cielo Verde Quebec Inc.
Pointe-Claire, Canada
11.2023 - Current
- Managed Change Controls and quality documentation to ensure compliance with Health Canada and internationally regulations and internal Quality Management System requirements.
- Authored, reviewed and maintained Standard Operating Procedures (SOPs), work instructions, forms and quality records.
- Led deviation investigations, root cause analysis and CAPA implementation to improve quality system effectiveness.
- Reviewed batch manufacturing records, Certificates of Analysis and supporting documentation prior to product release.
- Released raw materials, packaging components and finished products according to GMP requirements.
- Coordinated external laboratory testing, reviewed analytical results and maintained Certificates of Analysis.
- Supported internal, client and Health Canada audits through documentation review and inspection readiness activities.
- Collaborated closely with Production, Operations and Laboratory teams to resolve quality issues and implement continuous improvement initiatives.
- Assisted with supplier qualification, quality agreements and vendor performance monitoring.
- Supported regulatory submissions, Site Plan Amendments and documentation required by Health Canada.
- Served as acting QA Manager during management absence, independently reviewing quality documentation, approving quality records, supporting production, and coordinating daily quality assurance activities.
Analytical Chemist
Pathogenia Lab
Dorval, Canada
11.2022 - 12.2023
- Prepared technical reports, validation documentation, scientific summaries, and laboratory records.
- Maintained compliance with laboratory quality systems and documentation requirements.
- Performed analytical testing, scientific data review, trend analysis, data integration, and interpretation of laboratory results.
- Conducted troubleshooting, laboratory investigations, root cause analysis, and technical problem-solving activities.
- Coordinated analytical projects and collaborated with laboratory, quality, and management teams to achieve project objectives.
- Participated in internal and client audits while ensuring data integrity and regulatory compliance.
Quality Control Engineer
Modalal
, Iran
07.2014 - 09.2019
- Performed daily monitoring and verification of manufacturing equipment like extractors, evaporators, condensers to ensure operation within established process parameters and quality requirements.
- Verified process parameters including temperature, pressure and equipment performance.
- Conducted quality inspections, process monitoring activities, root cause investigations, and corrective action implementation.
- Prepared equipment performance reports and monitored process efficiency indicators to identify trends and areas for improvement.
- Collaborated with engineering and maintenance teams to troubleshoot production issues and improve process reliability.
- Participated in equipment qualification, commissioning, installation, and process optimization projects.
- Collaborated with production, engineering, procurement, and technical teams to align efforts with manufacturing objectives and drive continuous improvement initiatives.
- Participated in supplier selection, qualification, and technical evaluation activities for raw materials and manufacturing equipment.
- Assisted with sourcing and purchasing activities related to raw materials, manufacturing equipment, and production supplies.
Education
Master of Chemical Engineering -
Université Laval
Quebec, CanadaBachelor of Chemical Engineering -
University of Science And Technology
TehranSkills
- Quality Management Systems (QMS)
- Document Control Systems
- High level of accuracy and attention to detail in GMP documentation
- Excellent organizational, time management, and prioritization skills
- Strong understanding of regulatory compliance and quality system requirements
- Supplier Quality Management
- Raw material sourcing
- Continuous Improvement
- Regulatory Documentation
- CAPA Management
- Deviations & Investigations
- SOP development
- Risk Assessment
- Root Cause Analysis
Languages
- English (Fluent)
- French (Intermediate)
- Persian (Native)
Timeline
Quality & Process Engineer
Cielo Verde Quebec Inc.
11.2023 - Current
Analytical Chemist
Pathogenia Lab
11.2022 - 12.2023
Quality Control Engineer
Modalal
07.2014 - 09.2019
Master of Chemical Engineering -
Université Laval
Bachelor of Chemical Engineering -
University of Science And Technology