Quality Assurance Associate

Insight Global; Toronto; On-site; CAD 90,000 - 110,000; Full time

Job summary

Insight Global in Toronto is seeking a Quality Assurance/Quality Control professional to ensure GMP compliance for Health Canada regulated products. The role focuses on product releases, deviations, CAPA, change control, document management, and supplier oversight.

You will review regulatory documents, manage 3PL warehouse activities, support investigations, audits, and training management. Strong communication and knowledge of Health Canada guidelines are essential.

Qualifications

• Minimum university degree in science or pharmacy.
• 5+ years in pharma QA/QC under Health Canada GMP.
• Excellent written and verbal communication.
• Proficient with MS Office and document control systems.

Responsibilities

• Review government, regulatory and corporate policies to ensure procedures meet requirements.
• Review batch documents and QMS events prior to batch release for distribution in line with Health Canada requirements.
• Maintain incoming inspection & release documents & supplier master documents.
• Coordinate warehouse QA activities for incoming inspection and release; manage 3PL warehouse-related activities.
• Manage Method Transfer activities & assist supervisor with New Product Launches.
• Manage third-party lab testing and annual confirmatory testing program.
• Review stability and validation reports to comply with Canadian GMP.
• Initiate, investigate, closeout, and manage all nonconformance deviations and change controls (Canada).
• Ensure timely CAPA implementation and support for complaint investigations.
• Communicate with sites to receive APQRs and Stability Reports; act on corrective actions.
• Evaluate returned products and provide disposition.
• Participate in audits, audit responses, and closure of CAPAs.
• Prepare, review, and manage SOPs and training.
• Perform other duties as assigned.

Skills

Excellent communication

Health Canada guidelines

GMP and regulatory

MS Office proficiency

Education

B.Sc. in science or pharmacy

Job description

This position is responsible for ensuring quality systems work properly and in compliance with Good Manufacturing Practices and Health Canada Guidelines. This position is responsible for monitoring GMP-related activities for the company such as Product Releases, Deviation Management, Change Control Management, CAPA Management, Master document Management, SOP Management, Annual Confirmatory Testing program, and 3pl warehouse activities, etc.

Responsibilities:

• Review government, regulatory and corporate policies to ensure all procedures are current and meet requirements
• Review batch documents and other associated documents / QMS Events prior to batch release for distribution in line with Health Canada requirements.
• Maintain incoming inspection & release documents & supplier master documents.
• Co-ordinate warehouse QA activities for incoming inspection and release based on determined priorities. Manage 3pl- warehouse-related activities.
• Manage Method Transfer activities & assist supervisor with New Product Launches.
• Manage third-party lab testing for applicable products and manage the annual confirmatory testing program.
• Review stability reports, validation reports, and associated documents required to comply with Canadian GMP.
• Initiation, Investigation, review, closeout, and management of all Internal & external Nonconformance Deviations report pertaining to Canada Market products.
• Ensure initiation, review, closeout, and management of all internal & external change control records pertains to Canada Market products.
• Ensure the timely implementation of Identified CAPAs.
• Provides support for complaint investigations by logging complaints, gathering relevant information, following on corrective actions for timely approval, and closure of complaints.
• Communicate with sites to receive APQRs and Stability Reports as per the schedule. Identify risks and work with sites on the corrective actions, if required.
• Evaluate returned products, associated documentation, and provide product disposition.
• Participate in audits, audit response, and closing of resulting CAPAs
• Preparation, Review, and Management of SOPs &Management of Training.
• Perform other duties as assigned by the supervisor.

Education/Experience/Knowledge:

• Minimum University level degree (B.Sc.) in a Science or Pharmacy discipline applicable to Health Canada Standards
• Minimum 5+ years of experience in the pharmaceutical industry, specifically in Quality Assurance/ Quality Control department working under Health Canada GMP regulations
• Excellent communication skills, both written and verbal
• Knowledge of Health Canada Guidelines will be preferred
• Knowledge of GMP and regulatory requirements for the pharmaceutical industry.
• Strong proficiency with applicable computer software and MS applications.

We may use artificial intelligence tools to assist with the screening, assessment, or selection of potential applicants for this position.

Vacancy:

This posting is for a currently vacant role, and the successful candidate will be hired into an existing open position.