Overview
Quality Assurance Specialist Jobs in Ontario, Canada at Intellectt Inc
Title: Quality Assurance Specialist
Company: Intellectt Inc
Location: Ontario, Canada
Job Title: Pharma Quality Assurance (QA) Specialist
Location: Ontario, Canada
Duration: 12-Month Contract
Position Summary: Our client is seeking a technically strong Quality Assurance (QA) Specialist with hands-on experience in pharmaceutical manufacturing within a GMP-regulated environment. This role will focus on quality systems oversight, batch record review, and ensuring compliance with regulatory requirements including Health Canada, FDA, and ICH guidelines. The ideal candidate will have a solid understanding of validation principles, data integrity, and risk-based quality management.
Key Responsibilities
- Perform detailed review and approval of batch production records, electronic and paper-based documentation for GMP compliance
- Lead and support deviation investigations, root cause analysis (RCA), and implementation of CAPA using risk-based approaches
- Manage and support Change Control processes, including impact and risk assessments
- Ensure adherence to Data Integrity principles (ALCOA+) across all quality systems and documentation
- Support process validation activities (IQ/OQ/PQ) and cleaning validation documentation review
- Conduct internal audits and provide support during regulatory inspections (Health Canada, FDA)
- Review and approve SOPs, protocols, reports, and validation documents
- Collaborate with Manufacturing, QC, Validation, and Regulatory teams to ensure quality and compliance across operations
Key Requirements
- Bachelor’s degree in Pharmacy, Chemistry, Chemical Engineering, or related scientific discipline
- Strong experience in pharmaceutical QA within GMP-regulated manufacturing environments
- In-depth knowledge of GMP (Health Canada, FDA 21 CFR Part 210/211, ICH guidelines)
- Hands-on experience with Deviation, CAPA, Change Control, and Quality Management Systems (QMS)
- Understanding of process validation, cleaning validation, and equipment qualification (IQ/OQ/PQ)
- Familiarity with Data Integrity requirements (ALCOA+) and electronic systems
- Strong technical writing, documentation review, and analytical skills
If this role isn’t a fit and you’re exploring other opportunities in the Life Sciences industry, please feel free to share your resume at [email protected]. Kindly note, no C2C inquiries
