Quality Assurance Specialist

6 days ago

Markham, Ontario, Canada NeilMed Pharmaceuticals Full time
Job Summary

The Quality Assurance Specialist will be responsible for ensuring the quality and compliance of commercial drug products released to the Canadian market. This role will involve the preparation and review of quality/compliance-related documentation, processing of samples and orders in the warehouse, and execution of other quality-related tasks and activities as assigned by QA Management.

Key Responsibilities
  • Quality Control and Compliance
    • Coordinate with foreign sites for the receipt, review, and updates to master documents to ensure compliance with Good Manufacturing Practices (GMPs) and product release activities.
    • Maintain and review in-house quality documents, including Standard Operating Procedures (SOPs), Annual Product Quality Reviews (APQR), stability reports, qualification/validation protocols and reports, artwork, temperature studies, etc.
  • Deviation and Complaint Investigations
    • Process deviation investigations, including report generation and any associated trend analysis.
    • Process product quality complaints, including report generation and any associated trend analysis.
  • Warehouse Operations
    • Regularly inspect and process samples and orders in the warehouse. This may include unpacking samples from boxes or packing and taping up boxes, sorting and packing returns, etc.
  • Documentation and Record-Keeping
    • Sustain an effective system for maintaining copies of documents received from clients/foreign sites as well as those submitted to Health Canada, allowing ease of location and retrieval of records.
  • Support and Collaboration
    • Provide support during audits/inspections (i.e., internal, client, third-party, or regulatory agencies) as required.
    • Provide support during recall/mock recall events as required.
    • Build and maintain a positive and productive liaison with internal and external contacts.
    • Participate in and support project teams and advise other departments on Quality Assurance issues and strategies when required.
  • Qualifications and Skills
    • Hold a Canadian University degree or a degree recognized as equivalent by a Canadian accreditation body.
    • At least 3 years' experience in the role and in a warehouse operations environment.
    • General knowledge of Health Canada GMP.
    • Experience co-hosting client audits.

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