Quality Assurance Specialist

at  Pharmeng Technology Inc

QUALITY ASSURANCE CONSULTANT

We are seeking an experienced Quality Assurance Consultant for a leading global biotechnology company that leverages the power of science to bring new medicines to patients in need. This position is remote with occasional client site visits in Mississauga. The ideal candidate will have a minimum of 10 years of experience with Health Canada audits and extensive knowledge of the differences in manufacturing requirements between Canada and the US.

QUALIFICATIONS:

• Education: A university degree in a science related to the work being carried out, preferably recognized by a Canadian accreditation body.
• Experience: Minimum 10 years of practical experience in Quality Assurance, with a strong focus on Health Canada regulations and GMP requirements.

SKILLS:

• Deep understanding of GUI-0036 and GUI-0100 regulations.
• Ability to manage and execute complex quality systems and audits.
• Strong documentation and reporting skills.
• Excellent communication and training abilities.
• Proven track record in hosting and managing Health Canada audits.
• Consultancy Experience: Prior experience as a consultant or contractor with the necessary qualifications to advise on compliance and quality assurance matters in the biotechnology or pharmaceutical industry.

• Health Canada Compliance: Ensure compliance with Health Canada regulations, including GUI-0036, GUI-0100, and GUI-0001, by guiding the client through audits and establishing compliant practices.
• Review & Release Documentation: Oversee and review release documentation such as Certificates of Analysis (CofA) and batch records for biologics, ensuring adherence to regulatory requirements.
• Clinical GMP Compliance: Provide expert guidance on Good Manufacturing Practices (GMP) related to clinical trials, ensuring that investigational medicinal products meet all necessary release criteria as per GUI-0036.
• Label Reviews: Conduct and manage label reviews, using pre-prepared templates or creating new ones to ensure compliance with regulatory expectations.
• Audit Preparation & Hosting: Leverage extensive experience in hosting Health Canada audits to prepare the client’s facilities, processes, and documentation for inspection.
• Training & Development: Provide training to client personnel on GUI-0036, GUI-0100, and other relevant regulations, emphasizing the differences between FDA and Health Canada expectations.
• Process Improvement & Gap Analysis: Assess current in-house systems, identify gaps, and recommend remediation strategies to align with regulatory standards. Provide detailed reports to guide quality improvements.