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Quality Assurance Specialist

2 months ago

Markham, Ontario, Canada NeilMed Pharmaceuticals Full time
Job Summary

The Quality Assurance Specialist will report to the Director, Quality Assurance and will support the execution of all quality-related tasks and activities undertaken by NeilMed Pharmaceuticals Inc. The successful candidate will be responsible for the release of commercial drug products to the Canadian market, the preparation and review of quality/compliance-related documentation, processing of samples and orders in the warehouse, and the execution of other quality-related tasks and activities as assigned by QA Management.

Key Responsibilities
  • Coordinate with foreign sites for the receipt, review, and updates to master documents to ensure compliance to GMPs and in relation to product release activities.
  • Maintain and review in-house quality documents, e.g. SOPs, APQR, stability reports, qualification/validation protocols and reports, artwork, temperature studies, etc.
  • Process deviation investigations, including report generation and any associated trend analysis.
  • Process product quality complaints, including report generation and any associated trend analysis.
  • Process changes and control requests, including report generation and any associated trend analysis.
  • 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.
  • 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.
  • 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.
  • Demonstrate ability to effectively prioritize, coordinate, and complete multiple projects within established timeframes.
Qualification Requirements
  • 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.
Skills and Competencies
  • Comprehensive knowledge of the Food and Drugs Act, Health Canada GMP, and Natural Health Product regulations and associated guidelines.
  • Demonstrated ability in the effective management of deviations, root cause analysis, and CAPA implementation.
  • The ability to identify pragmatic solutions to compliance/operational problems and challenges.
  • Strong attention to detail, proven data analysis skills, and the ability to present these findings effectively.
  • Ability to work both independently and in a team environment, always promoting positive, respectful, and professional relationships.
  • Strong proficiency in common office applications (e.g. MS Word, Excel, PowerPoint, Outlook, Adobe Acrobat, etc.) and the ability to achieve rapid fluency in business-related electronic applications/platforms (e.g., EQMS, EMS, WMS, CRM, etc.).
  • Excellent written and verbal communication skills.