Healthcare QA Specialist Qualified Person First

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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. Guarantee compliance related to art 52 dlgs 219/06.
2. Ensure all staff is trained in their respective job functions, including GMP.
3. Write and revise Standard Operating Procedures as required.
4. Conduct regular inspections of the facility and recordkeeping, including summarization and reporting of findings. Coordinate or assist with corrective actions and preventative measures.
5. Communicate with clients and provide information during external audits.
6. Liaise with Health Canada officials during regulatory audits.
7. Provide feedback and assistance to Customer/Client QA related questions and concerns.
8. Monitor the processes and systems within the Department to ensure regulatory compliance and effective operation.
9. Investigate discrepancies and problems, and advise the appropriate individuals of the findings.
10. Assist in the development of pro-active strategies as a preemptive measure against potential future problems with systems or processes.
11. Complete NCR reports and change control requests and provide necessary follow-up.
12. Perform maintenance, support, and continuous improvements of Quality Systems.
13. 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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