GMP- and ISO 22716-certified cosmetic contract manufacturing company
based in Canada. We specialize in
custom formulation, bulk manufacturing, filling, and turnkey solutions
for skincare, haircare, body care, and pet care products. With a strong focus on quality and compliance, we ensure every product we manufacture meets the highest standards of safety, efficacy, and regulatory requirements.
Role Summary
The
Quality Assurance & Regulatory Specialist
will oversee compliance with
Health Canada, ISO 22716, GMP, and MoCRA
requirements. This role ensures that all raw materials, packaging, production, and finished goods meet regulatory and quality standards. The specialist will also manage audits, develop SOPs, maintain certifications, and liaise with regulatory authorities.
Key ResponsibilitiesQuality Assurance (QA):
Ensure compliance with
ISO 22716, GMP, MoCRA, and Health Canada
requirements.
Develop, review, and update
SOPs, batch records, and QA documentation
.
Oversee
lot coding, labeling checks, and traceability systems
.
Review and approve
raw material COAs, finished product release, and stability testing reports
.
Conduct
internal audits and self-inspections
to ensure site compliance.
Manage the
Corrective and Preventive Action (CAPA)
program.
Coordinate with production to ensure equipment cleaning, sanitization, and pest control records are maintained.
Provide QA training to staff on GMP, ISO, and compliance updates.
Regulatory Affairs (RA):
Prepare and submit
Product Information Files (PIFs)
, Cosmetic Notification Forms (CNFs), and other regulatory filings.
Maintain
licenses and certifications
including GMP, ISO 22716, MoCRA, and Health Canada Site License.
Monitor global cosmetic regulatory changes (Health Canada, FDA, EU, UK) and update teams.
Ensure packaging and label claims comply with
regulatory guidelines
.
Review marketing and product claims for compliance with
Health Canada and international regulations
.
Act as the primary contact for regulatory agencies and external auditors.
Support clients with documentation needed for international market entry.
Basic Requirements
Bachelor's degree in
Pharmaceutical Sciences, Chemistry, Biology, or related field
.
2-5 years of experience
in QA, regulatory, or compliance roles (preferably in cosmetics, pharmaceuticals, or personal care).
Strong knowledge of
Health Canada regulations, ISO 22716, GMP, and MoCRA
.
Experience with
audits, SOP writing, and documentation systems
.
Excellent organizational, analytical, and communication skills.
Ability to work cross-functionally with R&D, production, and sales teams.