About us
We are a company dedicated to the production and sales of health supplements. With a focus on producing high-quality health products, we have expanded our presence to serve markets in both North America and China.
Responsibilities and Duties:
- Maintain the manufacturing/packaging licensing (issued by Health Canada: Establishment and Site Licenses).
- Initiates applications for product registration to foreign jurisdictions (emphasis are on corporate brands).
- Complete product regulatory applications leading to market authorization by the way of NPN, as well as the unique requirements of the US FDA (or other jurisdiction).
- Knowledge of the current regulations including latest amendments to ensure system and product compliance.
- Participate in internal GMP and third party audits.
- In a timely manner, provide technical reviews of legal document, including but not limited to: Quality Agreements, Manufacturing Agreements, Confidentiality Agreements, Non-disclosure Agreements, and Exclusivity Agreements.
- Manage and execute the Natural Health Product license applications as outlined in the Canadian Natural health product regulations.
- Review product labels and related promotional and advertising materials for domestic and export.
- Ensure that the Company's programs and ·products are compliant with the regulations.
- Write and review SOPs to ensure continuous compliance with GMP and regulatory compliances. Maintain GMP and SOP training for all employees in the company.
- Logging customer complaints, performing risk assessment & writing investigation reports.
- Conducting training on GMP & other regulatory standards, maintain training records.
- Create COA
- Complete daily GMP inspections and reports
- Track routine output and SOPs
- Provide assistance to Manager with the investigation of Non-Conformance Reports and Complaints
- Monitor environmental temperature and humidity
Preferred Qualifications and/or Experiences:
- B.Sc. degree or equivalent in an applicable discipline of science (chemistry, biochemistry or related), specific medical training (pharmacology, nutritional or related) or law.
- Three or more years of experience in the pharmaceutical or nutraceutical industry (previous experience in pharmaceutical manufacturing would be considered an asset).
- Advanced knowledge/understanding of Canadian regulatory issues for manufacturing/packaging of pharmaceutical/Nutraceutical products.
- Advanced knowledge of GMP and the US FDA regulations for manufacturing/packaging pharmaceutical or nutraceutical products.
- Demonstrated time management and project organizational skills.
- Fluent in English with excellent communication skills
Job Type: Full-time
Pay: $55,000.00-$65,000.00 per year
Benefits:
- Dental care
- Extended health care
- Vision care
Flexible language requirement:
Education:
- Bachelor's Degree (preferred)
Experience:
- quality assurance: 1 year (preferred)
Ability to Commute:
Work Location: In person
