Quality Assurance Officer (F/M)
Kohl & Frisch Limited
Primary Role of This Position The Quality Control Specialist shall ensure adherence to Health Canada Guideline GUI-0001 Good Manufacturing Practices (GMP) regarding activities applicable to a wholesaler as well as GUI-0069 Guidelines for Environmental Control of Drugs during Storage and Transportation. The activities and procedures governed by these guidelines have potential for direct impact on drug identity, strength, quality, and purity. Specifically, the Quality Control Specialist shall ensure adherence to the Regulations outlined below. The Quality Control Specialist reports all quality issues to the Operations Supervisor and the RA/QA Manager.
02.004 + Ensures Pest Control Program maintained + Contractor-recommended action items addressed + Ensures temperature-controlled areas remain in spec + Investigates non-conformances + Ensures instruments (probes) are calibrated + Certificates archived + Ensures facility and structures remain clean and in a state of repair
02.006 + Ensures training records are current and archived + Manufacturing Control C.02.012 + Monitors Recalls + Participates in Self-Inspections + Monitors corrective actions Quality Control C.02.013 + Ensures national Standard Operating Procedures (SOPs) are adhered to + Ensures local Work Instructions (WIs) are up to date and adhered to + Ensures Hold/Release Procedures are adhered to
Quality Control C.02.014 + Ensures Customer Returns are handled appropriately + Release for resale + Destruction Quality Control C.02.015 + Ensures Good Distribution Practices are adhered to + Participates in route profiling and shipping studies + Ensures Change Control is adhered to Records C.Qualifications Must be qualified by relevant academic training and experience + Bachelors Degree in Science or relevant education requirements + Experience working in a Health Canada licensed GMP-compliant environment + Experience working in a warehouse/distribution environment for a pharmaceutical/healthcare company is preferred + Strong communication skills: written and verbal; + Strong troubleshooting and risk mitigation skills; + Proficiency in computer applications including Microsoft Outlook and Office: Word, Excel, PowerPoint;
Hours of Work Monday to Friday 9:00am to 5:30pm. The Quality Control Specialist will be available to participate in Health Canada GMP audits.
Please ensure you specify the job title, QCS - Concord, in the subject line of your email.
Kohl & Frisch Limited welcomes applications from individuals with disabilities and provides accommodations upon request for candidates taking part in the selection process.
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