Company Description
Accord Healthcare Inc. is a dynamic pharmaceutical company dedicated to ensuring the safety, efficacy, and compliance of drug products. We are currently seeking a dynamic QA Associate to join our team.
Role Description
This is a full-time hybrid role for a Quality Assurance Associate with Accord Healthcare Canada, located in Kirkland, QC, with some work from home flexibility.
Responsibilities:
- Support product release and manage product life cycle from a Quality perspective for the Canadian market.
- Ensure compliance with Health Canada’s GMP and regulatory requirements for drug importers/distributors, including establishment licenses, API/FP GMPs, and recall procedures.
- Maintain and improve the Quality Management System (QMS) including handling change controls (CC), corrective and preventive actions (CAPA), deviations, out of specifications (OOS), investigations, product complaints, and Annual Product Quality Reviews (APQRs).
- Participate actively in Health Canada GMP and Compliance Audits.
- Evaluate change controls for product release process and ensure product compliance with the most current approved regulatory dossiers, including product release specifications, master manufacturing & packaging batch records, and process & packaging validation reports.
- Assess and report on deviations and investigations.
- Collaborate with various departments to maintain compliance.
Qualifications
- 1-2 years of experience in Quality Assurance within a Canadian pharmaceutical company.
- Knowledge of Canadian GMP requirements as per Health Canada guidance.
- Knowledge of Quality Management principles.
- Understanding of Health Canada’s compliance requirements for importer/distributor establishments.
- Strong organizational and communication skills.
- Ability to work both independently and in a hybrid environment.
- Dynamic self-starter and collaborative team player.
- Bachelor's degree in a relevant field such as Chemistry, Biology, or Pharmaceutical Sciences
- Experience in the pharmaceutical industry is a plus.
Job Types: Full-time, Permanent
Pay: $55,000.00-$65,000.00 per year
Work Location: Hybrid remote in Kirkland, QC H9H 3C4
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