Sharmila DORAIRAJ
Toronto,ON
Summary
Quality Assurance and Regulatory Affairs professional in pharmaceutical GMP, GLP, GCP, and ISO standards. Managed Drugs, Natural Health Products, and Cosmetic Products. Led the quality team expansion, resulting in improved operational efficiency through targeted, continuous improvement initiatives. Proven ability to manage complex projects and foster collaboration across functions, consistently delivering high-quality results under pressure. Highly-motivated employee with desire to take on new challenges. Strong work ethic, adaptability, and exceptional interpersonal skills. Adept at working effectively unsupervised and quickly mastering new skills.
Overview
11
11
years of professional experience
1
1
Certification
Work History
GxP Quality Assurance and Regulatory Affairs Lead
Ardent-Consultants
Brampton, ON
09.2023 - Current
- Manage compliance with local and international regulations for cosmetics, drugs, medical devices and other pharmaceutical products.
- Provide expert guidance on quality initiatives, leveraging regulatory knowledge for specialized tasks.
- Deliver tailored quality and regulatory compliance solutions, addressing backlog, and supporting strategic growth.
- Lead audit preparedness efforts, including regulatory remediation, and internal/external inspections.
- Conduct comprehensive SOP lifecycle management, performing gap analyses, and revising procedures.
- Maintain distribution control of SOPs, and develop training quizzes aligned with regulations.
- Executed quality assurance processes to uphold industry standards, and improve compliance.
Associate Director, Quality Assurance - EClinical Suite - ETMF, CTMs, EDC, EPRO, RTSM, Reporting & Safety
Axiom Real-time Metrics
Mississauga, ON
08.2020 - 08.2023
- Oversaw the design, implementation, and enhancement of Axiom’s GxP, ISO 9001, and ISO 13485-compliant Quality Management System (QMS).
- Proactively updated procedures, conducted training, and led audits to ensure QMS effectiveness.
- Collaborated with cross-functional teams to drive continuous improvements, supporting rapid company growth.
- Expanded the quality team from 5 to 13, managing documentation control and training, audits, CAPAs, deviations, and compliance functions.
- Helped transition from a paper-based Quality Management System to an electronic Quality Management System.
- Developed and reported quality metrics and KPIs, aligning frameworks with organizational goals.
- Led the design and implementation of quality systems, including SOPs and regulatory compliance, to boost efficiency.
- Provided strategic problem-solving solutions that influenced organizational development and improved quality outcomes.
- Directed complaint management teams to enhance external Quality Core Value Drivers.
- Led strategic initiatives to enhance operational workflows and efficiency.
- Managed cross-functional teams to improve project delivery and communication.
- Developed training programs to support staff development and knowledge sharing.
- Collaborated with stakeholders to define project scopes and objectives effectively.
- Oversaw the implementation of new technologies for improved data management.
- Streamlined reporting processes for better insights and data-driven decisions.
Director, Quality Assurance & Regulatory Affairs - Pharmaceutical Company
SEAFORD PHARMACEUTICALS INC.
Mississauga, ON
04.2017 - 06.2020
- Managed GMP compliance for the importation, manufacturing, storage, and distribution of high-quality drugs, natural health products, and cosmetic products locally and internationally.
- Oversaw adherence to Good Pharmacovigilance Procedures (GVP) standards to maintain product safety and regulatory compliance.
- Managed drug establishment and site licenses for warehouses, ensuring continuous industry regulation compliance.
- Obtained and managed Drug and Natural Health Products Licenses.
- Responsible for quality and compliance for over 15 manufacturing sites locally and internationally.
- Directed budget planning and resource allocation for projects.
- Collaborated with executive leadership on organizational strategy and vision.
- Fostered partnerships with key stakeholders to enhance business growth.
- Mentored department heads to improve operational efficiencies and performance.
- Facilitated training programs to enhance team skills and capabilities.
- Recruited, trained, supervised, evaluated and mentored staff members.
- Directed the organization's daily operations, ensuring compliance with applicable laws and regulations.
- Facilitated collaboration between teams by encouraging open communication channels.
- Conducted regular meetings with department heads to review progress on strategic initiatives.
- Developed policies and procedures to ensure compliance with corporate standards.
- Established relationships with vendors and suppliers to secure favorable terms for materials or services.
- Identified opportunities for improvement in operational performance metrics.
- Negotiated agreements with external partners such as contractors or consultants.
- Coordinated activities with other departments to expedite work and improve collaboration.
- Spearheaded the development and launch of new products or services.
Quality Assurance Specialist– Health Care Logistics (3PL Pharmaceutical Warehousing)
ACCURISTIX
Vaughan, ON
08.2016 - 03.2017
- Managed multiple client accounts, ensuring secure and GMP-compliant importation and distribution of pharmaceuticals and cosmetics across Canada.
- Collaborated with internal teams, clients, and transportation partners to meet regulatory requirements efficiently.
- Oversaw compliant handling of high-value products, valued over $30 million, maintaining accuracy in a high-volume environment.
- Conducted thorough audits to ensure compliance with regulatory standards.
- Trained staff on quality control procedures and best practices.
- Consulted with management and personnel to educate on QA standards.
- Developed and maintained quality assurance protocols, processes and procedures.
- Performed root cause analysis of nonconformance identified during testing cycles.
Technologist / Manager Support – Contract - Diphtheria, Tetanus & PPD Bulk Vaccine Manufacturing
SANOFI PASTEUR
Toronto, ON
06.2015 - 07.2016
- Supported the Deputy Director in overseeing compliance for diphtheria, tetanus, and PPD bulk vaccine manufacturing processes (upstream and downstream).
- Ensured adherence to local and international regulatory guidelines, site policies, and industry best practices across cross-functional teams.
- Independently reviewed and approved 150+ logs in upstream and downstream processes, ensuring compliance with SOPs.
- Coordinated with staff to communicate deviations, initiated investigations, and worked closely with quality personnel for resolution.
- Participated in continuous improvement initiatives to optimize operational workflows.
- Collaborated with other technologists in order to develop innovative solutions.
- Collaborated with cross-functional teams to enhance product quality and safety standards.
QA Manager – Medical Marijuana Licensing & Manufacturing
THC Meds Ontario Inc
Uxbridge, ON
06.2015 - 09.2015
- Collaborated with SPIC and A/RPIC teams to support the licensing and development of quality documentation for medical marijuana.
- Drafted, reviewed, and updated Standard Operating Procedures (SOPs) to meet regulatory compliance.
- Managed quality assurance and compliance operations within a licensed cannabis cultivation facility.
- Developed and implemented quality assurance protocols for cannabis products.
- Conducted regular audits to maintain product quality and safety standards.
- Trained staff on quality control processes and best practices.
- Collaborated with production teams to resolve quality issues promptly.
- Reviewed and updated standard operating procedures for quality assurance practices.
- Monitored testing procedures to ensure accurate product evaluations.
- Facilitated continuous improvement initiatives within the QA department.
- Managed daily activities of QA/QC for clients.
Quality Assurance and Regulatory Affairs-Associate / Account Manager-Consulting
Eurofins Biopharma (previously Experm Laboratories)
Toronto, ON
05.2014 - 05.2015
- Managed multiple client accounts, delivering comprehensive Quality Assurance, and Regulatory Affairs solutions.
- Applied extensive expertise in GMP, cGMP, GVP, and GPP processes to ensure compliance with Health Canada and FDA regulations.
- Provided technical support for pharmaceutical clients across Life Sciences, Cosmetics, Medical Devices, and Medical Marijuana sectors.
Senior Inspector Quality Assurance and Regulatory Affairs (GLP/GCP/GMP)-CRO-Nonclinical & Clinical (Phase I)
CHARLES RIVER LABORATORIES
Montreal, QC
06.2003 - 04.2014
- Managed nonclinical and Phase I clinical studies for global pharmaceutical and biotechnology organizations.
- Conducted audits of records, protocols, reports, and facilities to ensure compliance with FDA and international regulations.
- Performed study monitoring to verify adherence to regulatory standards and protocols, enhancing client outcomes.
Education
Mini-MBA: Essentials of Management - Management And Strategy
Schulich ExecEd | Schulich School of Business | York University
Toronto, ON09-2024
Bachelor of Science - Biotechnology, Honours
University of Wollongong
AustraliaSkills
- Health Canada, FDA, and EMA regulations
- GMP, GLP, and GCP expertise
- ISO 9001 and ISO 13485 compliance
- Drug Establishment License & Site License
- Drugs, natural health products, and cosmetic expertise
- Quality management systems
- Standard operating procedures
- Change control and CAPA management
- Pharmacovigilance and compliance
- Vendor management strategies
- Internal audits
- Project management proficiency
- Continuous improvement initiatives
- Quality systems software experience
- Regulatory compliance
- Audit preparation
- Quality Management Systems (including eQMS)
- SOP development
- CAPA management
- Continuous improvement
- GxP standards
- Stakeholder collaboration
- Project delivery
- Effective communication
- Training development
- Problem solving
- Team leadership
- Excellent communication
- Cross-functional teamwork
Affiliations
- Past Board Member, Canadian Chapter, Society of Quality Assurance
- Past Member, Society of Quality Assurance
- Past Active Member, Consumer Health Products Canada
- Past Active Member, Canadian Association of Professionals in Regulatory Affairs (CAPRA)
Certification
- GCP for Clinical Investigational Drugs and Biologics (ICH Focus) - CITI Program - Expires Feb 2024
- GCP for Clinical Investigations of Devices - CITI Program - Expires Feb 2024
- ISO 14001:2015 - The Aspects and Impacts on Environmental Management System
- ISO 9001:2015 Requirements (Training Provider & Examiner Certification Scheme) Industry provided GMP Certification & Training
- Introduction to Regulatory Affairs Level I (96%) | Academy of Applied Pharmaceutical Sciences
- Registered Quality Assurance Professional in Good Laboratory Practice (RQAP-GLP) certification | Society of Quality Assurance
References
References available upon request.
Training
- CHP Canada Product Quality Sub-Committee bilateral meeting with Health Canada (RORB)
- Canadian Association of Professionals in Regulatory Affairs-CAPRA Education
- CCSQA (Canadian Chapter for the Society of Quality Assurance) annual meetings
- PSG 1-day workshop “A Day with the Inspectors (Health Canada)”
- Various Health Canada Webinars
- Pharmaceutical Advertising Advisory Board (PAAB) Workshop & Training
- IQVIA Life Science Symposium
- WHMIS training
Timeline
GxP Quality Assurance and Regulatory Affairs Lead
Ardent-Consultants
09.2023 - Current
Associate Director, Quality Assurance - EClinical Suite - ETMF, CTMs, EDC, EPRO, RTSM, Reporting & Safety
Axiom Real-time Metrics
08.2020 - 08.2023
Director, Quality Assurance & Regulatory Affairs - Pharmaceutical Company
SEAFORD PHARMACEUTICALS INC.
04.2017 - 06.2020
Quality Assurance Specialist– Health Care Logistics (3PL Pharmaceutical Warehousing)
ACCURISTIX
08.2016 - 03.2017
Technologist / Manager Support – Contract - Diphtheria, Tetanus & PPD Bulk Vaccine Manufacturing
SANOFI PASTEUR
06.2015 - 07.2016
QA Manager – Medical Marijuana Licensing & Manufacturing
THC Meds Ontario Inc
06.2015 - 09.2015
Quality Assurance and Regulatory Affairs-Associate / Account Manager-Consulting
Eurofins Biopharma (previously Experm Laboratories)
05.2014 - 05.2015
Senior Inspector Quality Assurance and Regulatory Affairs (GLP/GCP/GMP)-CRO-Nonclinical & Clinical (Phase I)
CHARLES RIVER LABORATORIES
06.2003 - 04.2014
Mini-MBA: Essentials of Management - Management And Strategy
Schulich ExecEd | Schulich School of Business | York University
Bachelor of Science - Biotechnology, Honours
University of Wollongong