What a GMP quality assurance specialist does
GMP quality assurance specialists make sure drugs are made, tested, packaged and stored under Health Canada's good manufacturing practices, set out in Part C, Division 2 of the Food and Drug Regulations. They review executed batch records, investigate deviations and out-of-specification results, manage change control and corrective and preventive actions, approve standard operating procedures and support Health Canada inspections. Their judgement often decides whether a lot is released. Weak quality systems can lead to inspection observations, recalls or problems with your drug establishment licence.
Quality assurance in a GMP plant is different from quality control on a general production line, and it differs again between sterile products, solid dosage forms, natural health products and packaging-only sites. Finch asks about the dosage forms a candidate has worked with, the inspections they supported and the systems they used to manage deviations and training. Some sites need someone close to the floor; others need a documentation and auditing specialist. We match the person to the gap in your quality team.
Typical responsibilities
- Review executed batch records and supporting documents before product release
- Lead or support deviation, complaint and out-of-specification investigations
- Manage change control and track corrective and preventive actions to closure
- Write, revise and approve standard operating procedures
- Conduct internal audits and supplier qualification audits
- Prepare for and host Health Canada GMP inspections and client audits
Qualifications and credentials
- A degree or diploma in chemistry, microbiology, pharmacy, biology or a related science
- Experience applying Health Canada GMP requirements and its GMP guide for drug products (GUI-0001)
- Familiarity with the Natural Health Products Regulations, ISO 13485 or international GMP expectations where your products require them
- Experience with electronic quality management systems and data integrity principles
- ASQ certifications such as Certified Quality Auditor (CQA), which some employers value
Who hires a GMP quality assurance specialist
- Pharmaceutical and generic drug manufacturers
- Natural health product manufacturers
- Contract manufacturing and packaging organizations
- Drug importers, distributors and testing laboratories
Where we recruit GMP quality assurance specialist candidates
We fill GMP quality assurance specialist roles for employers across Toronto and the GTA, including North York, Scarborough, Etobicoke, Vaughan, Markham, Richmond Hill, Mississauga, Brampton, Oakville, Burlington, Oshawa and Pickering, and for employers across Canada. GTA employers can meet us at our North York office by appointment.
What Finch checks before you meet a candidate
- Confirm the dosage forms and product types they have supported
- Ask about their role in Health Canada inspections and how observations were closed
- Review their experience with deviation, CAPA and change control systems
- Discuss how they respond to pressure to release a batch with an open investigation
- Check references from quality managers or heads of quality
Interview questions to ask
- Tell me about a deviation investigation you led. How did you reach the root cause?
- Production wants a lot released today, but one batch record entry is unclear. What do you do?
- How do you build data integrity checks into your review of laboratory and production records?