Location: 243 Consumers Road, Toronto, Ontario, M2J 4W8
Why this role is important?Job Title: Sr.Quality Assurance Specialist
Reports to: Director, Quality Assurance
Department: Sanis Health Inc, Quality Assurance
Date Prepared: Jul-06-2026
SummaryReporting to the Director, Quality Assurance, this role supports quality assurance activities at Sanis. The Sr. Quality Assurance Specialist will ensure that all pharmaceutical manufacturing, testing, product release, distribution and post market surveillance activities of third party manufactured products are carried out in compliance with Good Manufacturing Practices (GMP), Health Canada regulations, and other applicable corporate standards and procedures.
Essential Duties and Responsibilities- Responsible for finished goods product releases and ensuring that batch production records are complete, accurate and in compliance;
- Actively manage and maintain third party documentation in Product Master Files (PMF's) and ensure PMF's are kept up to date on an ongoing basis.
- Reviews and assess vendor deviations, CAPAs and change controls
- Assist in reviewing and writing SOPs according to GMP requirements
- Actively support Sanis Quality Assurance Systems relating to training, deviations, product complaint, product recalls, CAPA's, stability, annual product requirements and change controls
- Review annual product quality reports (APQR's)
- Support vendor compliance inspection or audits
- Support Director, Quality Assurance as required in the implementation of projects to improve processes and procedures and reduce operating costs.
- Support Manager, Regulatory Affairs as required for labelling review and update and provincial submission documentation preparation and filing.
- Participate on project teams as required.
Skills- Able to work with minimal of supervision and rutilizes decision making skills to achieve specific organizational objectives with consideration given to their impact on other work groups.
- Adaptable to set and prioritize work with varying exceptions.
- Able to work with diverse personalities and styles.
- Advanced understanding of Quality Assurance policies and procedures in a manufacturing environment.
- Sound knowledge of compliance and regulatory components, auditing skills, and quality systems.
- Communicates with clarity, both verbally (in one on one or group situations) and in writing by composing clear email communication, documents and/or presentations.
- Proof-reading is required of manufacturing documentation and test results.
- Computer skills to produce effective reports, documents, spreadsheets, and presentations.
- Proficiency with Microsoft Office applications (Outlook, Excel, Word, PowerPoint, Teams), ERP systems (SAP) and electronic QMS Systems (TrackWise, Veeva, ZenQMS, etc).
Supervision/Leadership- This position does not have any direct reports but will provide coaching and support to other team members.
Education- Requires a university degree in sciences; pharmacy, chemistry, microbiology, biology or similar, recognized as equivalent to Canadian science degree.
- Completion of a post-graduate diploma in pharmaceutical regulatory affairs or quality assurance would be an asset.
- Bilingual in French would be an asset.
- undefined
Experience- Minimum of 5 years' experience in a quality role in a pharma company, preferably in quality assurance in a pharma manufacturing environment.
- Self-motivated; highly organized with the ability to work in a fast-paced environment.
- Good technical writing skills.
- Strong interpersonal and communication skills to initiate necessary actions with third party organizations and internal stakeholders.
- Good communication skills (both written and verbal)Project management experience and / or ability.
- Experience with regulatory drug submissions an asset
Employment Type:Full time
Type of Role:Regular
Please Note: If you have Employee Self Service (ESS) on Workday, apply to this job via the Workday application.Hiring Range / c9chelle salariale e0 l'embauche :
$68,000.00 - $93,500.00 / 68.000,00$ - 93.500,00$ (per year / par an)
A candidate's experience and knowledge as well as the geographical region in which the position is located may be factored into the pay a candidate receives for this position. This posting is for a newly created position. The Company uses artificial intelligence for the purpose of screening, assessing and/or selecting applicants for this position. / L'expe9rience et les connaissances d'un candidat ainsi que la re9gion ge9ographique dans laquelle le poste est situe9 peuvent eatre prises en compte dans la re9mune9ration qu'un candidat ree7oit pour ce poste. Cette offre d'emploi concerne un poste nouvellement cre9e9. L'entreprise utilise l'intelligence artificielle dans le but de filtrer, d'e9valuer et/ou de se9lectionner les candidats e0 ce poste.
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