Qualified Person - QA Specialist

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Job Description:

Job Summary
This position monitors the overall Quality System status of the distribution center. This position acts in compliance with drug, medical device, and local regulations. Ensures quality processes are maintained through the implementation of procedures, training, and regular inspections.

Responsibilities:

1. Ensures all staff is trained in their respective job functions, including GMP.
2. Writes and revises Standard Operating Procedures as required.
3. Conducts regular inspections of the facility and recordkeeping, including summarization and reporting of findings. Coordinates or assists with corrective actions and preventative measures.
4. Communicates with clients and provides information during external audits.
5. Liaises with Health Canada officials during regulatory audits.
6. Provides feedback and assistance to Customer/Client QA related questions and concerns.
7. Monitors the processes and systems within the Department to ensure regulatory compliance and effective operation.
8. Investigates discrepancies and problems and advises the appropriate individuals of the findings.
9. Assists in the development of pro-active strategies as a preemptive measure against potential future problems with systems or processes.
10. Completes NCR reports and change control requests and provides necessary follow-up.
11. Performs maintenance, support, and continuous improvements of Quality Systems.
12. QPIC designation duties.

Qualifications:

1. Pharmaceutical, Healthcare or Food Industry Experience - Preferred
2. Quality Assurance experience - Preferred
3. Bachelor’s Degree in Science related field (or internationally comparable degree) required - Preferred
4. QPIC/AQPIC Designation - Preferred

Employee Type: Permanent

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